STRUNG DENTAL ROLLS— 510(k) K872810

Clearance details

Applicant

American Silk Sutures, Inc.

Product code

Code EFN

Device class

Class 1

Regulation

21 CFR 872.6050

Advisory panel

Dental

Date received

1987-07-14

Decision date

1987-12-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lynn, MA, US

• K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER1987-04-30
• K863764 — COTTON ROLLS, NON-STERILE1986-10-27
• 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

• K922143 — AMERICAN BURN SHEET1992-08-10
• K904514 — STRUNG TELFA NON-ADHERENT SPONGE1991-03-27
• K902921 — RAYON NEUROLOGICAL SPONGE1990-09-18
• K872951 — AMERICAN BRAIN RETRACTOR COVER1987-09-16
• K872905 — AMERICAN NASAL SPONGE1987-09-04

• Z-1799-2016 — American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K872810.