The following data is part of a premarket notification filed by Humboldt Products with the FDA for Surgical Retractor & Elastic Stays, Disp.
| Device ID | K812562 |
| 510k Number | K812562 |
| Device Name: | SURGICAL RETRACTOR & ELASTIC STAYS, DISP |
| Classification | Hook, Surgical, General & Plastic Surgery |
| Applicant | HUMBOLDT PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-08 |
| Decision Date | 1981-10-02 |