COTTON ROLLS, NON-STERILE— 510(k) K863764

Clearance details

Applicant

The Medical Group, Inc.

Product code

Code EFN

Device class

Class 1

Regulation

21 CFR 872.6050

Advisory panel

Dental

Date received

1986-09-25

Decision date

1986-10-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reno, NV, US

• K872810 — STRUNG DENTAL ROLLS1987-12-04
• K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER1987-04-30
• K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE1986-08-06
• K861727 — COTTON FILLED GAUZE SPONGES 2 X 21986-07-10
• K843539 — TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-1985-05-23

• K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 21991-06-06
• K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM1990-03-30
• K881843 — PEDIATRIC HOSPITAL BED1988-10-26
• K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM1988-07-14
• K870282 — 4 X 4 SPONGES, NON-STERILE1987-02-24

• Z-2158-2013 — Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.Class II·Terminated·MicroAire Surgical Instruments, LLC·20130812
• Z-2159-2013 — Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T 1624-109 1648-609 1624-509 1648-609T 1624-509T 1628-509 1632-509 1632-609 A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.Class II·Terminated·MicroAire Surgical Instruments, LLC·20130812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K863764.