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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
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