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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, Occlusive
510(k) Number K874480
Device Name MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)
Applicant
Omikron Scientific, Ltd.
Kiryat Weizmann
P.O.B. 2012, Rehovot 76120
Israel,  IL
Applicant Contact MARC COLES
Correspondent
Omikron Scientific, Ltd.
Kiryat Weizmann
P.O.B. 2012, Rehovot 76120
Israel,  IL
Correspondent Contact MARC COLES
Regulation Number878.4020
Classification Product Code
NAD  
Date Received11/02/1987
Decision Date 02/22/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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