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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K992438
Device Name INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
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 Number884.5310
Classification Product Code
LTZ  
Date Received07/22/1999
Decision Date 08/02/1999
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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