510(k) K122246
- Device
- MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
- Applicant
- CELLERATION, INC.
- 510(k) number
- K122246
- Product code
- NRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-13
- Date received
- 2012-07-27
- Regulation
- 878.4410
- Classification name
- Wound Cleaner, Ultrasound
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHY SIMPSON
- Address
- 6321 Bury Dr., Suite 15 Eden Prairie MN US 55346 55346
FDA Registration Numbers#
- 1424263
- 1423662
- 1928237
- 2435119
- 3004028690
- 1062240
- 2183613
- 3004961578
- 1450662
- 1720929
- 3007225330
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator | Alliqua Biomedical, Inc. | 2016-12-22 |
| K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | Celleration, Inc. | 2014-08-13 |
| K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2014-05-16 |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2013-03-05 |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Misonix, Inc. | 2011-12-01 |
| K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2009-06-19 |
| K050129 | CELLERATION MIST THERAPY SYSTEM 5.1 | Celleration, Inc. | 2005-05-17 |
| DEN040004 | CELLERATION MIST THERAPY SYSTEM | Celleration | 2004-06-25 |
Legacy Summary#
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FDA Review#
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