The following data is part of a premarket notification filed by Instranetics, Inc. with the FDA for Instra-safe.
| Device ID | K823430 |
| 510k Number | K823430 |
| Device Name: | INSTRA-SAFE |
| Classification | Tray, Surgical, Instrument |
| Applicant | INSTRANETICS, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-16 |
| Decision Date | 1983-01-07 |