The following data is part of a premarket notification filed by Magnum Diamond, Inc. with the FDA for Diamond Blade Surgical Knives.
| Device ID | K895752 |
| 510k Number | K895752 |
| Device Name: | DIAMOND BLADE SURGICAL KNIVES |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | MAGNUM DIAMOND, INC. P.O. BOX 368 Rapid City, SD 57701 |
| Contact | Carol Rae |
| Correspondent | Carol Rae MAGNUM DIAMOND, INC. P.O. BOX 368 Rapid City, SD 57701 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-10-17 |