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 |