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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K014129
Device Name PROMOGRAN MATRIX WOUND DRESSING
Applicant
Johnson & Johnson Medical, Ltd.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact SERGIO J GADALETA
Correspondent
Johnson & Johnson Medical, Ltd.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact SERGIO J GADALETA
Classification Product Code
KGN  
Date Received12/17/2001
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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