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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 K864323
Device Name CYTOLOGY BRUSHES
Applicant
MEDICAL PACKAGING CORP.
7252 GREENTREE RD.
BETHESDA,  MD  20817
Applicant Contact JOYCE T DAVIS
Correspondent
MEDICAL PACKAGING CORP.
7252 GREENTREE RD.
BETHESDA,  MD  20817
Correspondent Contact JOYCE T DAVIS
Regulation Number884.4530
Classification Product Code
HHT  
Date Received11/03/1986
Decision Date 01/09/1987
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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