The following data is part of a premarket notification filed by Celleration, Inc. with the FDA for Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator.
| Device ID | K140782 |
| 510k Number | K140782 |
| Device Name: | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR |
| Classification | Wound Cleaner, Ultrasound |
| Applicant | CELLERATION, INC. 6321 BURY DRIVE, STE 15 Eden Prairie, MN 55346 |
| Contact | Kathy Simpson |
| Correspondent | Kathy Simpson CELLERATION, INC. 6321 BURY DRIVE, STE 15 Eden Prairie, MN 55346 |
| Product Code | NRB |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816789010239 | K140782 | 000 |
| 00816789010211 | K140782 | 000 |
| 10816789010201 | K140782 | 000 |
| 00812265010348 | K140782 | 000 |
| 00812265010331 | K140782 | 000 |
| 00812265010324 | K140782 | 000 |
| 00812265010317 | K140782 | 000 |