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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 K900308
Device Name SPERM SELECT SYSTEM
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact ALBERT P MAYO
Regulation Number884.5250
Classification Product Code
HDR  
Date Received01/22/1990
Decision Date 04/13/1990
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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