BIOFILL BIOCELLULOSE DRESSING STERILE— 510(k) K950621

Name: FDA 510(k) clearance K950621
Creator: U.S. Food and Drug Administration
Published: 1995-12-26

Substantially Equivalent

The Purdue Frederick Co.

FDA 510(k) clearance K950621 for BIOFILL BIOCELLULOSE DRESSING STERILE, Substantially Equivalent on 1995-12-26. Applicant: The Purdue Frederick Co.. Device class: 1.

Clearance details

Applicant: The Purdue Frederick Co.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-02-10
Decision date: 1995-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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

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