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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name snare, flexible
510(k) Number K911482
Device Name LAPAROSCOPIC SNARE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Applicant Contact DEAN SECREST
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Correspondent Contact DEAN SECREST
Regulation Number876.4300
Classification Product Code
FDI  
Date Received04/04/1991
Decision Date 04/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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