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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K840756
Device Name BIOPATCH BOVINE PERICARDIAL PATCH
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
103 Bauer Dr.
P.O. Box 530
Oakland,  NJ  07436
Applicant Contact ANTHONY C PARKS
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
103 Bauer Dr.
P.O. Box 530
Oakland,  NJ  07436
Correspondent Contact ANTHONY C PARKS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/23/1984
Decision Date 02/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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