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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K101961
Device Name TIGERPAW SYSTEM
Applicant
Laax, Inc.
8 Snowberry Ct.
Orinda,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
Laax, Inc.
8 Snowberry Ct.
Orinda,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/12/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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