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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 K902995
Device Name PC-BEADS POSTCOITAL TEST
Applicant
Microscopy Research Innovations
4203 Towanda Trail
Knoxville,  TN  37919
Applicant Contact DOODY, MD
Correspondent
Microscopy Research Innovations
4203 Towanda Trail
Knoxville,  TN  37919
Correspondent Contact DOODY, MD
Regulation Number884.4530
Classification Product Code
HHT  
Date Received07/09/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
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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