The following data is part of a premarket notification filed by Alton Design, Llc with the FDA for Alton Pt Stepper.
| Device ID | K024183 |
| 510k Number | K024183 |
| Device Name: | ALTON PT STEPPER |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ALTON DESIGN, LLC 2655 N. OCEAN DR. SUITE 403 Singer Island, FL 33404 |
| Contact | Greg Wiita |
| Correspondent | Greg Wiita ALTON DESIGN, LLC 2655 N. OCEAN DR. SUITE 403 Singer Island, FL 33404 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-19 |
| Decision Date | 2003-03-17 |
| Summary: | summary |