STERILE ESMARCH BANDAGE— 510(k) K881176

Name: FDA 510(k) clearance K881176
Creator: U.S. Food and Drug Administration
Published: 1988-04-11

Substantially Equivalent

Spectrum/Hydro-Med Products, Inc.

FDA 510(k) clearance K881176 for STERILE ESMARCH BANDAGE, Substantially Equivalent on 1988-04-11. Applicant: Spectrum/Hydro-Med Products, Inc.. Device class: 1.

Clearance details

Applicant: Spectrum/Hydro-Med Products, Inc.
Product code: Code GAX
Device class: Class 1
Regulation: 21 CFR 878.5900
Advisory panel: General, Plastic Surgery
Date received: 1988-03-18
Decision date: 1988-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAX

view all

K931198 — UNIQUET1993-09-01
K881398 — TOURNIQUET1988-04-29
K875092 — DEGANIA SILICONE TOURNIQUET1988-01-07
K873928 — UNIVERSAL TOURNIQUET1987-10-23
K872003 — KINDERWRAP1987-06-23

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