The following data is part of a premarket notification filed by Magnum Diamond, Inc. with the FDA for Micron-scope.
| Device ID | K853499 |
| 510k Number | K853499 |
| Device Name: | MICRON-SCOPE |
| Classification | Knife, Ophthalmic |
| Applicant | MAGNUM DIAMOND, INC. 3875 E. SOUTH CROSS-B San Antonio, TX 78222 |
| Contact | Doug Mastel |
| Correspondent | Doug Mastel MAGNUM DIAMOND, INC. 3875 E. SOUTH CROSS-B San Antonio, TX 78222 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-09-24 |