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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K872849
FOIA Releasable 510(k) K872849
Device Name SPERM-SELECT ADDITIONAL INDICATION
Applicant
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Applicant Contact ALBERT P MAYO
Correspondent
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Correspondent Contact ALBERT P MAYO
Regulation Number884.5250
Classification Product Code
HDR  
Date Received07/20/1987
Decision Date 09/28/1987
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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