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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 K912325
Device Name MICRO-PAP(TM) KIT
Applicant
MICRO-PAP CORP.
1812 MURIEL COURT
PRINCETON,  NJ  08540
Applicant Contact JOHN G RICHARDSON
Correspondent
MICRO-PAP CORP.
1812 MURIEL COURT
PRINCETON,  NJ  08540
Correspondent Contact JOHN G RICHARDSON
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/24/1991
Decision Date 05/02/1994
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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