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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 K923143
Device Name CYTO PAK PAP SMEAR KIT
Applicant
International Medical Equipment Brokers, Inc.
6451 El Camino Real
Suite A
Carlsbad,  CA  92009
Applicant Contact DEBORAH KRUEGER
Correspondent
International Medical Equipment Brokers, Inc.
6451 El Camino Real
Suite A
Carlsbad,  CA  92009
Correspondent Contact DEBORAH KRUEGER
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/29/1992
Decision Date 07/16/1993
Decision Substantially Equivalent - Kit (SESK)
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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