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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, Surgical
510(k) Number K911475
Device Name LAPAROSCOPIC VESSEL ARTICULATOR
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 Number870.4475
Classification Product Code
DWP  
Date Received04/04/1991
Decision Date 07/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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