The following data is part of a premarket notification filed by Reddy Medtech Health Products Ltd. with the FDA for Latex Condoms Natural Colour With Silicone Oil Lubricant.
| Device ID | K974323 |
| 510k Number | K974323 |
| Device Name: | LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT |
| Classification | Condom |
| Applicant | REDDY MEDTECH HEALTH PRODUCTS LTD. 9 WEBSTER COURT Plainsboro, NJ 08536 |
| Contact | Ravi Reddy |
| Correspondent | Ravi Reddy REDDY MEDTECH HEALTH PRODUCTS LTD. 9 WEBSTER COURT Plainsboro, NJ 08536 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1998-02-10 |