The following data is part of a premarket notification filed by Medtec Inc. Dba Civco Medical Solutions with the FDA for Solstice Srs Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask.
| Device ID | K182079 |
| 510k Number | K182079 |
| Device Name: | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC Inc. Dba CIVCO Medical Solutions 1401 8th Street SE Orange City, IA 51041 -3020 |
| Contact | Alena Newgren |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439112519 | K182079 | 000 |
| 00841439113714 | K182079 | 000 |
| 00841439113233 | K182079 | 000 |
| 00841439113240 | K182079 | 000 |
| 00841439112557 | K182079 | 000 |
| 00841439112564 | K182079 | 000 |
| 00841439112571 | K182079 | 000 |
| 00841439112588 | K182079 | 000 |
| 00841439112489 | K182079 | 000 |
| 00841439112496 | K182079 | 000 |
| 00841439112502 | K182079 | 000 |
| 00841439113448 | K182079 | 000 |