The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Urological Catheter.
| Device ID | K881646 |
| 510k Number | K881646 |
| Device Name: | UROLOGICAL CATHETER |
| Classification | Catheter, Urological |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | S Densmore |
| Correspondent | S Densmore COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-06-16 |