The following data is part of a premarket notification filed by Fujifilm Medwork Gmbh with the FDA for Jazz Suction Valve, Jazz Air/water Valve, Jazz Forceps Valve.
| Device ID | K210625 |
| 510k Number | K210625 |
| Device Name: | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve |
| Classification | Endoscope Channel Accessory |
| Applicant | FUJIFILM Medwork GmbH Medworkring 1 Hochstadt, DE 91315 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-02 |
| Decision Date | 2021-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04044503055828 | K210625 | 000 |