The following data is part of a premarket notification filed by General Polymers with the FDA for Bouser's Urinal.
| Device ID | K970465 |
| 510k Number | K970465 |
| Device Name: | BOUSER'S URINAL |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | GENERAL POLYMERS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 10012 |
| Contact | Milton N Beneke Jr. |
| Correspondent | Milton N Beneke Jr. GENERAL POLYMERS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 10012 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-12-18 |