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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K002109
Device Name OLEEVA FOAM
Applicant
Bio Med Sciences, Inc.
1111 Hamilton St.
Allentown,  PA  18101
Applicant Contact MARK E DILLON
Correspondent
Bio Med Sciences, Inc.
1111 Hamilton St.
Allentown,  PA  18101
Correspondent Contact MARK E DILLON
Regulation Number878.4025
Classification Product Code
MDA  
Date Received07/12/2000
Decision Date 08/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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