The following data is part of a premarket notification filed by Omni-tract Surgical, Div. Minn. Scientific, Inc. with the FDA for Mri Fastsystem Retractor System.
| Device ID | K001339 |
| 510k Number | K001339 |
| Device Name: | MRI FASTSYSTEM RETRACTOR SYSTEM |
| Classification | Retractor |
| Applicant | OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Contact | Catherine Miller |
| Correspondent | Catherine Miller OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-27 |
| Decision Date | 2000-05-17 |