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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 And Burn, Occlusive
510(k) Number K912032
Device Name SILON(TM) TRANSPARENT WOUND DRESSING
Applicant
Bio Med Sciences, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact MARK E DILLON
Correspondent
Bio Med Sciences, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact MARK E DILLON
Classification Product Code
MGP  
Date Received05/08/1991
Decision Date 08/20/1991
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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