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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 K022614
Device Name INVIGRA
Applicant
INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH,  IN 500 016
Applicant Contact P. JANARDHAN REDDY
Correspondent
INDUS MEDICARE LTD.
144, S.P. RD., BEGUMPET
HYDERABAD ANDHRA PRADESH,  IN 500 016
Correspondent Contact P. JANARDHAN REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/06/2002
Decision Date 04/08/2003
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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