The following data is part of a premarket notification filed by Titan Condoms with the FDA for Innerwear/extrawear/jimmy-o Raincoat/zeus/gentlemen's Choice.
| Device ID | K970792 |
| 510k Number | K970792 |
| Device Name: | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE |
| Classification | Condom |
| Applicant | TITAN CONDOMS 3111 WEST POST RD. Las Vegas, NV 89118 |
| Contact | Lillie C Thomas |
| Correspondent | Lillie C Thomas TITAN CONDOMS 3111 WEST POST RD. Las Vegas, NV 89118 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-06-02 |