The following data is part of a premarket notification filed by Celleration, Inc. with the FDA for Celleration Mist Therapy System 5.1.
| Device ID | K050129 |
| 510k Number | K050129 |
| Device Name: | CELLERATION MIST THERAPY SYSTEM 5.1 |
| Classification | Wound Cleaner, Ultrasound |
| Applicant | CELLERATION, INC. 10250 VALEY VIEW ROAD SUITE 137 Eden Prairie, MN 55344 |
| Contact | David Bremseth |
| Correspondent | David Bremseth CELLERATION, INC. 10250 VALEY VIEW ROAD SUITE 137 Eden Prairie, MN 55344 |
| Product Code | NRB |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-19 |
| Decision Date | 2005-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816789010253 | K050129 | 000 |