MICROPOROUS HYPOALLERGENIC— 510(k) K840946

Substantially Equivalent

Gainor Medical

FDA 510(k) clearance K840946 for MICROPOROUS HYPOALLERGENIC, Substantially Equivalent on 1984-08-17. Applicant: Gainor Medical. Device class: 2.

Clearance details

Applicant: Gainor Medical
Product code: Code KGW
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1984-03-05
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional

Download summary PDF View on FDA.gov ↗

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More clearances from Gainor Medical

K850100 — BLOOD LANCET1987-01-29
K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED1985-02-21
K844305 — GAINOR MEDICAL FLOWMAX NEEDLES1984-11-30
K844306 — GAINOR MEDICAL SYRINGE1984-11-30
K840945 — SKIN CLOSURE1984-10-31

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