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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K991374
Device Name INVIGRA
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 Number884.5300
Classification Product Code
HIS  
Date Received04/21/1999
Decision Date 06/15/1999
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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