The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Surface Applicator, Model 710257.
| Device ID | K083734 |
| 510k Number | K083734 |
| Device Name: | AXXENT SURFACE APPLICATOR, MODEL 710257 |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Contact | Steve Lin |
| Correspondent | Steve Lin XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005649 | K083734 | 000 |
| 00858012005410 | K083734 | 000 |
| 00858012005427 | K083734 | 000 |
| 00858012005434 | K083734 | 000 |
| 00858012005441 | K083734 | 000 |
| 00858012005595 | K083734 | 000 |
| 00858012005618 | K083734 | 000 |
| 00858012005625 | K083734 | 000 |
| 00858012005632 | K083734 | 000 |
| 00858012005359 | K083734 | 000 |