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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
Predetermined Change
Control Plan Authorized		 No
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