The following data is part of a premarket notification filed by Indus Medicare Ltd. with the FDA for Invigra Plus (with Spermicidal Lubricant).
Device ID | K992438 |
510k Number | K992438 |
Device Name: | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) |
Classification | Condom With Nonoxynol-9 |
Applicant | INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh, IN 500 016 |
Contact | P.k. Reddy |
Correspondent | P.k. Reddy INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh, IN 500 016 |
Product Code | LTZ |
CFR Regulation Number | 884.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-22 |
Decision Date | 1999-08-02 |