The following data is part of a premarket notification filed by Medical Sterilization, Inc. with the FDA for Msi Surgi-grade Suture Tray.
| Device ID | K843564 |
| 510k Number | K843564 |
| Device Name: | MSI SURGI-GRADE SUTURE TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | MEDICAL STERILIZATION, INC. NY 11791 - |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-10 |
| Decision Date | 1984-10-31 |