The following data is part of a premarket notification filed by Aktina Medical Corporation with the FDA for Thermoplastic Masks.
| Device ID | K192102 |
| 510k Number | K192102 |
| Device Name: | Thermoplastic Masks |
| Classification | Accelerator, Linear, Medical |
| Applicant | Aktina Medical Corporation 360 North Route 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella Aktina Medical Corporation 360 North Route 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365408011 | K192102 | 000 |
| B365407321 | K192102 | 000 |
| B365407231 | K192102 | 000 |
| B365407221 | K192102 | 000 |
| B365407411 | K192102 | 000 |