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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 K062433
Device Name DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
Applicant
Diamics, Inc.
Six Hamilton Landing Suite 200
Novato,  CA  94949
Applicant Contact PETER GOMBRICH
Correspondent
Diamics, Inc.
Six Hamilton Landing Suite 200
Novato,  CA  94949
Correspondent Contact PETER GOMBRICH
Regulation Number884.4530
Classification Product Code
HHT  
Date Received08/21/2006
Decision Date 03/16/2007
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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