The following data is part of a premarket notification filed by Solo-sled, Llc. with the FDA for Solo-sled.
| Device ID | K970090 |
| 510k Number | K970090 |
| Device Name: | SOLO-SLED |
| Classification | Cassette, Radiographic Film |
| Applicant | SOLO-SLED, LLC. 2413 VANCE AVE. P.O.BOX 3718 Chattanooga, TN 37404 |
| Contact | Patricia A Roddy |
| Correspondent | Patricia A Roddy SOLO-SLED, LLC. 2413 VANCE AVE. P.O.BOX 3718 Chattanooga, TN 37404 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1997-04-21 |
| Summary: | summary |