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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 K851934
Device Name CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
Applicant
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Applicant Contact CORINNE M AMBROSINO
Correspondent
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Correspondent Contact CORINNE M AMBROSINO
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/06/1985
Decision Date 07/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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