The following data is part of a premarket notification filed by Lukens Corp. with the FDA for Handles, Blade, Surgical.
| Device ID | K770800 |
| 510k Number | K770800 |
| Device Name: | HANDLES, BLADE, SURGICAL |
| Classification | Blade, Scalpel |
| Applicant | LUKENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-02 |
| Decision Date | 1977-05-06 |