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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 K040109
Device Name HEMORRHAGE OCCLUDER PIN
Applicant
TOOLS FOR SURGERY, LLC
1339 STONY BROOK ROAD
STONY BROOK,  NY  11790
Applicant Contact ARNOLD R LEIBOFF
Correspondent
TOOLS FOR SURGERY, LLC
1339 STONY BROOK ROAD
STONY BROOK,  NY  11790
Correspondent Contact ARNOLD R LEIBOFF
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/20/2004
Decision Date 03/25/2004
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
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