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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 K862242
Device Name PAP SMEAR KIT
Applicant
QUALI-MED, INC.
525 JULIE RIVERS DR.
SUITE 100
SUGAR LAND,  TX  77478
Applicant Contact RICK FOSTER
Correspondent
QUALI-MED, INC.
525 JULIE RIVERS DR.
SUITE 100
SUGAR LAND,  TX  77478
Correspondent Contact RICK FOSTER
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/12/1986
Decision Date 06/26/1986
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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