The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Universal Urethral Catheter.
| Device ID | K946282 |
| 510k Number | K946282 |
| Device Name: | UNIVERSAL URETHRAL CATHETER |
| Classification | Catheter, Coude |
| Applicant | LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Contact | David Phelps |
| Correspondent | David Phelps LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Product Code | EZC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-03-31 |