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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 K093351
Device Name COLLAWOUND ART
Applicant
Collamatrix, Inc.
26f, # 105, Section 2 Dunhua
South Rd., Da-An Distric
Taipei,  TW 106
Applicant Contact DENNIS J.N. SEAH
Correspondent
Collamatrix, Inc.
26f, # 105, Section 2 Dunhua
South Rd., Da-An Distric
Taipei,  TW 106
Correspondent Contact DENNIS J.N. SEAH
Classification Product Code
FRO  
Date Received10/27/2009
Decision Date 06/16/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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