The following data is part of a premarket notification filed by Indus Medicare Ltd. with the FDA for Invigra Male Latex Condom Green Colored And Mint Flavored.
| Device ID | K000038 |
| 510k Number | K000038 |
| Device Name: | INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED |
| Classification | Condom |
| 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 | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-06 |
| Decision Date | 2000-03-21 |