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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Air, Non-Manual, For Endoscope
510(k) Number K101146
Device Name WATER BOTTLE CAP SYSTEM
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact CARROLL L MARTIN
Correspondent
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact CARROLL L MARTIN
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received04/23/2010
Decision Date 07/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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