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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 K000040
Device Name INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
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 Received01/06/2000
Decision Date 03/21/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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