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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844052
Device Name BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
Applicant
Woodroof Laboratories, Inc.
3100-7 Harvard St.
Santa Ana,  CA  92704
Applicant Contact AUBREY WOODROOF
Correspondent
Woodroof Laboratories, Inc.
3100-7 Harvard St.
Santa Ana,  CA  92704
Correspondent Contact AUBREY WOODROOF
Date Received10/18/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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