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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K980356
Device Name CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
Applicant
Canadian Medical Brush, Inc.
2299 Drew Rd.
Unit 6
Mississauga,  CA L55 1A3
Applicant Contact STEPHEN JEMUOVIE
Correspondent
Canadian Medical Brush, Inc.
2299 Drew Rd.
Unit 6
Mississauga,  CA L55 1A3
Correspondent Contact STEPHEN JEMUOVIE
Regulation Number884.4530
Classification Product Code
HHT  
Date Received01/29/1998
Decision Date 04/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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