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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Surgical, General & Plastic Surgery
510(k) Number K153358
Device Name Standard Clamp
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Applicant Contact ALISON SATHE
Correspondent
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Correspondent Contact ALISON SATHE
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received11/20/2015
Decision Date 05/02/2016
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
Predetermined Change
Control Plan Authorized		 No
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