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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 K070269
Device Name MODIFICATION TO COLLAWOUND DRESSING
Applicant
Collamatrix Co., Inc.
# 360 Ruiguang Rd., 2nd Floor
Neihu District
Taipei,  TW 114
Applicant Contact DENNIS J SEAH
Correspondent
Collamatrix Co., Inc.
# 360 Ruiguang Rd., 2nd Floor
Neihu District
Taipei,  TW 114
Correspondent Contact DENNIS J SEAH
Classification Product Code
KGN  
Date Received01/29/2007
Decision Date 03/02/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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