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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 K851885
Device Name OMIDERM WOUND & BURN DRESSING
Applicant
Biosystems Assoc.
Prospect Plz.
P.O. Box 144
La Jolla,  CA  92038
Applicant Contact ELIE A SHNEOUR
Correspondent
Biosystems Assoc.
Prospect Plz.
P.O. Box 144
La Jolla,  CA  92038
Correspondent Contact ELIE A SHNEOUR
Classification Product Code
FRO  
Date Received04/30/1985
Decision Date 11/25/1985
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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