The following data is part of a premarket notification filed by Riley Medical, Inc. with the FDA for Surgical Instrument Tray.
| Device ID | K944025 |
| 510k Number | K944025 |
| Device Name: | SURGICAL INSTRUMENT TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | RILEY MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane E Minear |
| Correspondent | Diane E Minear RILEY MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-17 |
| Decision Date | 1994-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007871 | K944025 | 000 |
| 00821925007864 | K944025 | 000 |
| 00821925007857 | K944025 | 000 |