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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom with nonoxynol-9
510(k) Number K992438
Device Name INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
Applicant
INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH,  IN 500 016
Applicant Contact P.K. REDDY
Correspondent
INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH,  IN 500 016
Correspondent Contact P.K. REDDY
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received07/22/1999
Decision Date 08/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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