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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anoscope And Accessories
510(k) Number K020702
Device Name O'REGAN DISPOSABLE ANOSCOPE
Applicant
Canadian Theatre Products , Ltd.
#210-828 Harbouside Dr.
North Vancouver, B.C.,  CA V7P 3R9
Applicant Contact ANN-MARIE O'KEEFE
Correspondent
Canadian Theatre Products , Ltd.
#210-828 Harbouside Dr.
North Vancouver, B.C.,  CA V7P 3R9
Correspondent Contact ANN-MARIE O'KEEFE
Regulation Number876.1500
Classification Product Code
FER  
Date Received03/04/2002
Decision Date 03/29/2002
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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