The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Sterile Water For Device Irrigation/ Sterile Saline For Device Irrigation.
| Device ID | K973734 |
| 510k Number | K973734 |
| Device Name: | STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION |
| Classification | Catheter And Tip, Suction |
| Applicant | WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1998-02-05 |
| Summary: | summary |