The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for Care + Plus Irregation Tray.
| Device ID | K863281 |
| 510k Number | K863281 |
| Device Name: | CARE + PLUS IRREGATION TRAY |
| Classification | Catheter, Urological |
| Applicant | WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Contact | David B Peters |
| Correspondent | David B Peters WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-10-31 |