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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, Drug
510(k) Number K033523
Device Name COLLAGEN-ORC ANTIMICROBIAL MATRIX
Applicant
Johnson & Johnson Medical, Ltd.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact JOHN D PAULSON
Correspondent
Johnson & Johnson Medical, Ltd.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact JOHN D PAULSON
Classification Product Code
FRO  
Date Received11/07/2003
Decision Date 10/21/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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