The following data is part of a premarket notification filed by Omni-tract Surgical, Div. Minn. Scientific, Inc. with the FDA for Mass (micro-access Spine System).
| Device ID | K992583 |
| 510k Number | K992583 |
| Device Name: | MASS (MICRO-ACCESS SPINE SYSTEM) |
| Classification | Arthroscope |
| Applicant | OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Contact | Michael Pontius |
| Correspondent | Michael Pontius OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis, MN 55413 -1660 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-10-29 |
| Summary: | summary |