The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for 16 Long Catheter W/adapter, 14 Fr And 12 Fr.
| Device ID | K885202 |
| 510k Number | K885202 |
| Device Name: | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR |
| Classification | Catheter, Urological |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | Teresa R Mccleery |
| Correspondent | Teresa R Mccleery 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 | 1988-12-16 |
| Decision Date | 1989-01-31 |