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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K181608
Device Name Disposable 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 Number876.1500
Classification Product Code
GCJ  
Date Received06/19/2018
Decision Date 09/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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