K844052Substantially Equivalent

Biobrane Brand Temp. Wound Dressing W/adhesive

Name: K844052 Biobrane Brand Temp. Wound Dressing W/adhesive
Creator: Woodroof Laboratories, Inc.
Published: 1985-01-23
License: https://open.fda.gov/license/

Woodroof Laboratories, Inc., Santa Ana CA / Traditional, Substantially Equivalent

FDA source

K844052 is the FDA 510(k) clearance record for BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE, cleared for Woodroof Laboratories, Inc. on 1985-01-23. FDA records list 2 510(k) clearances for Woodroof Laboratories, Inc., from 1979-05-03 to 1985-01-23. As of 2026-09-10, FDA records show no recalls naming K844052.

Clearance record

Decision date: 1985-01-23
Received: 1984-10-18 (97 days to decision)
Review panel: Unknown
Applicant: Woodroof Laboratories, Inc. 3100-7 Harvard St., Santa Ana CA
Third party review: No