The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Vaginal Applicator.
| Device ID | K072616 |
| 510k Number | K072616 |
| Device Name: | AXXENT VAGINAL APPLICATOR |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 -7301 |
| Contact | Eric Hashemian |
| Correspondent | Eric Hashemian XOFT, INC. 49000 MILMONT DRIVE Fremont, CA 94538 -7301 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005502 | K072616 | 000 |
| 00858012005496 | K072616 | 000 |
| 00858012005489 | K072616 | 000 |
| 00858012005472 | K072616 | 000 |
| 00858012005465 | K072616 | 000 |
| 00858012005458 | K072616 | 000 |