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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 K020223
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 Received01/22/2002
Decision Date 03/04/2002
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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