STERILE DENTAL ROLL— 510(k) K812709

Substantially Equivalent

Medspec Corp.

FDA 510(k) clearance K812709 for STERILE DENTAL ROLL, Substantially Equivalent on 1981-10-23. Applicant: Medspec Corp.. Device class: 1.

Clearance details

Applicant: Medspec Corp.
Product code: Code EFN
Device class: Class 1
Regulation: 21 CFR 872.6050
Advisory panel: Dental
Date received: 1981-09-24
Decision date: 1981-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFN

K872810 — STRUNG DENTAL ROLLS1987-12-04
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

More clearances from Medspec Corp.

K813012 — STERILE BASIN SETS1981-11-06
K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT1981-11-02
K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT1981-11-02
K812711 — STERILE GAUZE PADS 12PLY1981-11-02
K810071 — STERILE SILICONE TUBING1981-02-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.