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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K023051
Device Name INTRAUTERINE DELIVERY SYSTEM - INJECTOR
Applicant
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
Prosurg, Inc.
2193 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/13/2002
Decision Date 12/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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