The following data is part of a premarket notification filed by Minnesota Scientific, Inc. with the FDA for Omni-tract Chest Wall & Luna Retractor.
| Device ID | K853947 |
| 510k Number | K853947 |
| Device Name: | OMNI-TRACT CHEST WALL & LUNA RETRACTOR |
| Classification | Retractor |
| Applicant | MINNESOTA SCIENTIFIC, INC. 2520 KENNEDY ST. NE MINNEAPOLIS, MN 55413 |
| Contact | BRUCE A LEVAHN |
| Correspondent | BRUCE A LEVAHN MINNESOTA SCIENTIFIC, INC. 2520 KENNEDY ST. NE MINNEAPOLIS, MN 55413 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-16 |