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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 K890706
Device Name CYTOBRUSH
Applicant
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES
23 WELISEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/10/1989
Decision Date 04/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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