SPYROFOAM WOUND DRESSING— 510(k) K951730

Name: FDA 510(k) clearance K951730
Creator: U.S. Food and Drug Administration
Published: 1995-06-16

Substantially Equivalent

Polymedica Industries, Inc.

FDA 510(k) clearance K951730 for SPYROFOAM WOUND DRESSING, Substantially Equivalent on 1995-06-16. Applicant: Polymedica Industries, Inc.. Device class: 1.

Clearance details

Applicant: Polymedica Industries, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-04-14
Decision date: 1995-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden,, CO, 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 Polymedica Industries, Inc.

view all

K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED1997-10-24
K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER1997-05-02
K964701 — MITRAFLEX PIGMENTED WOUND DRESSING1997-02-07
K963623 — SPYROFLEX PIGMENTED WOUND DRESSING1996-10-25
K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER1996-09-12

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