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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K870352
Device Name RUBYCELL(TM) SYNTHETIC ISLAND DRESSING
Applicant
Bioderm, Inc.
P.O. Box 4882
Wheaton,  IL  60189
Applicant Contact OLIVIER A DELANNOY
Correspondent
Bioderm, Inc.
P.O. Box 4882
Wheaton,  IL  60189
Correspondent Contact OLIVIER A DELANNOY
Classification Product Code
FRO  
Date Received01/29/1987
Decision Date 02/26/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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