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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K093725
Device Name CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
Applicant
Canada Endoscope Corporation
1590 Oakburn St.
Pickering, On,  CA L1V 6M9
Applicant Contact ROGER LECLERC
Correspondent
Canada Endoscope Corporation
1590 Oakburn St.
Pickering, On,  CA L1V 6M9
Correspondent Contact ROGER LECLERC
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received12/03/2009
Decision Date 08/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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