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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Surgical, Gynecological
510(k) Number K911474
Device Name LAPAROSCOPIC FORCEPS
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 Number884.4530
Classification Product Code
HCZ  
Date Received04/04/1991
Decision Date 07/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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