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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 K111064
Device Name TIGERPAW SYSTEM II
Applicant
LAAX, INC.
8 SNOWBERRY COURT
ORINDA,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
LAAX, INC.
8 SNOWBERRY COURT
ORINDA,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
FTL  
Date Received04/18/2011
Decision Date 05/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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