The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Suture Rack & Needle Counter.
| Device ID | K760428 |
| 510k Number | K760428 |
| Device Name: | SUTURE RACK & NEEDLE COUNTER |
| Classification | Tray, Surgical, Instrument |
| Applicant | KLEEN TEST PRODUCTS 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 | 1976-08-13 |
| Decision Date | 1976-11-02 |