GAUZE SPONGE,STERILE 2'S— 510(k) K912779

Substantially Equivalent

Keilei Intl., Inc.

FDA 510(k) clearance K912779 for GAUZE SPONGE,STERILE 2'S, Substantially Equivalent on 1991-09-30. Applicant: Keilei Intl., Inc.. Device class: 1.

Clearance details

Applicant: Keilei Intl., Inc.
Product code: Code NAB
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 1991-06-24
Decision date: 1991-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Keilei Intl., Inc.

K913779 — BANDAGE ROLL, GAUZE1991-12-04
K913575 — GAUZE PACKING, SURGICAL STERILE AND NON-STERILE1991-09-06
K895372 — X-RAY DETECTABLE GAUZE SPONGE1989-11-03
K895086 — GAUZE SPONGE1989-10-23

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