The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Accorde(r) Irrigating Syringe/procedure Tray.
| Device ID | K904158 |
| 510k Number | K904158 |
| Device Name: | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Contact | Richard P Welch |
| Correspondent | Richard P Welch WELCON, INC. 99 HARTFORD AVE. Providence, RI 02909 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-07 |
| Decision Date | 1990-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15075024 | K904158 | 000 |
| B15072020 | K904158 | 000 |
| B15072014 | K904158 | 000 |
| B15072010 | K904158 | 000 |
| B150372324 | K904158 | 000 |
| B150372320 | K904158 | 000 |
| B150372314 | K904158 | 000 |
| B150372310 | K904158 | 000 |
| B150372024 | K904158 | 000 |
| B150372020 | K904158 | 000 |
| 20612479107780 | K904158 | 000 |
| B15072024 | K904158 | 000 |
| B15073010 | K904158 | 000 |
| B15075020 | K904158 | 000 |
| B15075014 | K904158 | 000 |
| B15075010 | K904158 | 000 |
| B15074024 | K904158 | 000 |
| B15074020 | K904158 | 000 |
| B15074014 | K904158 | 000 |
| B15074010 | K904158 | 000 |
| B15073024 | K904158 | 000 |
| B15073020 | K904158 | 000 |
| B15073014 | K904158 | 000 |
| 20612479101320 | K904158 | 000 |