The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Sterile Urethral Catheterization Tray.
| Device ID | K850285 |
| 510k Number | K850285 |
| Device Name: | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY |
| Classification | Catheter, Urological |
| Applicant | PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn, WI 53121 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-02-28 |