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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 K093253
Device Name AMID STAPLER
Applicant
SAFESTITCH LLC
8282 SHADOW WOOD BLVD
CORAL SPRINGS,  FL  33071
Applicant Contact STEWART DAVIS
Correspondent
SAFESTITCH LLC
8282 SHADOW WOOD BLVD
CORAL SPRINGS,  FL  33071
Correspondent Contact STEWART DAVIS
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received10/16/2009
Decision Date 11/12/2009
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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