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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 K132472
Device Name JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
Applicant
JUSTRIGHT SURGICAL, LLC
128 Blye HIll Landing
Newbury,  NH  03255
Applicant Contact MICHELE LUCEY
Correspondent
JUSTRIGHT SURGICAL, LLC
128 Blye HIll Landing
Newbury,  NH  03255
Correspondent Contact MICHELE LUCEY
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/07/2013
Decision Date 02/11/2014
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
Recalls CDRH Recalls
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