INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

Condom With Nonoxynol-9

INDUS MEDICARE LTD.

The following data is part of a premarket notification filed by Indus Medicare Ltd. with the FDA for Invigra Plus (with Spermicidal Lubricant).

Pre-market Notification Details

Device IDK992438
510k NumberK992438
Device Name:INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
ClassificationCondom With Nonoxynol-9
Applicant INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh,  IN 500 016
ContactP.k. Reddy
CorrespondentP.k. Reddy
INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh,  IN 500 016
Product CodeLTZ  
CFR Regulation Number884.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-22
Decision Date1999-08-02

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