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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K120814
Device Name PADLOCK CLIP-12
Applicant
Aponos Medical Corp.
16 Hillside Rd.
Kingston,  NH  03848
Applicant Contact JOHN FEE
Correspondent
Aponos Medical Corp.
16 Hillside Rd.
Kingston,  NH  03848
Correspondent Contact JOHN FEE
Regulation Number876.4400
Classification Product Code
PKL  
Date Received03/19/2012
Decision Date 09/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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