HYPERGEL PROTECTIVE WOUND GEL— 510(k) K905439

Name: FDA 510(k) clearance K905439
Creator: U.S. Food and Drug Administration
Published: 1991-05-29

Substantially Equivalent

Scott Health Care

FDA 510(k) clearance K905439 for HYPERGEL PROTECTIVE WOUND GEL, Substantially Equivalent on 1991-05-29. Applicant: Scott Health Care. Device class: 1.

Clearance details

Applicant: Scott Health Care
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1990-12-04
Decision date: 1991-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMF

view all

K241916 — TearRepair Liquid Skin Protectant2024-09-27
K182733 — Rochal Bioshield Silicone Film2019-06-27
K171148 — Aleo BME Liquid Bandage2018-01-12
K153571 — Cavilon Advanced High Endurance Skin Protectant2016-08-23
K160684 — Atteris No-Sting Skin Protectant2016-07-26

More clearances from Scott Health Care

view all

K954275 — MEPORE PLUS (9X15CM)1995-12-27
K954274 — MEPORE (6X7)1995-12-19
K945206 — ALLDRESS MULTI LAYERED WOUND DRESSING1995-01-12
K932743 — MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION1993-09-10
K910857 — ALLDRESS MULTI LAYERED WOUND DRESSING1991-04-12

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