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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Storage Cover
510(k) Number K951104
Device Name ENDOBOOT
Applicant
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Applicant Contact GRETCHEN YOUNKER
Correspondent
United States Endoscopy Group, Inc.
9330 Progress Pkwy.
Mentor,  OH  44060
Correspondent Contact GRETCHEN YOUNKER
Regulation Number876.1500
Classification Product Code
OCU  
Date Received03/10/1995
Decision Date 04/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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