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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K952947
Device Name DELPORE SKIN CLOSURE
Applicant
Bitco Intl.
2010 Corporate Ridge #410
Mclean,  VA  22102
Applicant Contact TERRY INGRAM
Correspondent
Bitco Intl.
2010 Corporate Ridge #410
Mclean,  VA  22102
Correspondent Contact TERRY INGRAM
Regulation Number880.5240
Classification Product Code
FPX  
Date Received06/26/1995
Decision Date 07/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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