The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Welcon Sterile Water For Device Irrigation; Welcon Sterile 0.9% Normal Saline For Device Irrigation.
| Device ID | K003402 |
| 510k Number | K003402 |
| Device Name: | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION |
| Classification | Catheter And Tip, Suction |
| Applicant | WELCON, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau WELCON, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-05-01 |