COTTON ROLLS— 510(k) K802429

Substantially Equivalent

Worldwide Surgical Gauze

FDA 510(k) clearance K802429 for COTTON ROLLS, Substantially Equivalent on 1980-10-23. Applicant: Worldwide Surgical Gauze. Device class: 1.

Clearance details

Applicant: Worldwide Surgical Gauze
Product code: Code EFN
Device class: Class 1
Regulation: 21 CFR 872.6050
Advisory panel: Dental
Date received: 1980-10-03
Decision date: 1980-10-23
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 Worldwide Surgical Gauze

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