The following data is part of a premarket notification filed by Titan Condoms Llc with the FDA for Titan Condoms.
| Device ID | K210208 |
| 510k Number | K210208 |
| Device Name: | Titan Condoms |
| Classification | Condom |
| Applicant | Titan Condoms LLC 1950 Elkhorn Ct. Unit. 210 San Mateo, CA 94403 |
| Contact | Neville Muringayi |
| Correspondent | George Hattub Medicsense USA 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-26 |
| Decision Date | 2022-02-17 |