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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 K140367
Device Name ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
Applicant
Harbor Medtech, Inc.
4 Jenner
Suite 190
Irvine,  CA  92618
Applicant Contact JERRY MEZGER
Correspondent
Harbor Medtech, Inc.
4 Jenner
Suite 190
Irvine,  CA  92618
Correspondent Contact JERRY MEZGER
Classification Product Code
KGN  
Date Received02/14/2014
Decision Date 09/12/2014
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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