The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Waters Ileal Reservoir Catheter.
| Device ID | K813494 |
| 510k Number | K813494 |
| Device Name: | WATERS ILEAL RESERVOIR CATHETER |
| Classification | Catheter, Rectal For Continent Ileostomy |
| Applicant | WATERS INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KPH |
| CFR Regulation Number | 876.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-14 |
| Decision Date | 1981-12-31 |