The following data is part of a premarket notification filed by Avacen Inc. with the FDA for Avacen 100.
| Device ID | K133981 |
| 510k Number | K133981 |
| Device Name: | AVACEN 100 |
| Classification | Pad, Heating, Powered |
| Applicant | AVACEN INC. 7920 SILVERTON AVENUE SUITE L San Diego, CA 92126 |
| Contact | Thomas G Muehlabuer |
| Correspondent | Thomas G Muehlabuer AVACEN INC. 7920 SILVERTON AVENUE SUITE L San Diego, CA 92126 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862800000334 | K133981 | 000 |
| 00862800000327 | K133981 | 000 |
| 00862800000310 | K133981 | 000 |
| 00862800000303 | K133981 | 000 |
| 00862800000358 | K133981 | 000 |
| 00862800000396 | K133981 | 000 |
| 00862800000389 | K133981 | 000 |
| 00862800000372 | K133981 | 000 |
| 00862800000341 | K133981 | 000 |