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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 K090894
Device Name COLLAWOUND WOUND DRESSING
Applicant
Collamatrix Co., Inc.
26f, # 105, Section 2
Dunhua S. Rd., Da-An Dist.
Taipei,  TW 106
Applicant Contact DENNIS J.N. SEAH
Correspondent
Collamatrix Co., Inc.
26f, # 105, Section 2
Dunhua S. Rd., Da-An Dist.
Taipei,  TW 106
Correspondent Contact DENNIS J.N. SEAH
Classification Product Code
KGN  
Date Received03/31/2009
Decision Date 06/25/2009
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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