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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 K861017
Device Name GALENICA'S DISPOSABLE ANOSCOPES
Applicant
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Applicant Contact JACQUES MARCOTTE
Correspondent
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Correspondent Contact JACQUES MARCOTTE
Regulation Number876.1500
Classification Product Code
FER  
Date Received03/18/1986
Decision Date 06/13/1986
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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