MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12— 510(k) K122246
Substantially EquivalentCelleration, Inc.
FDA 510(k) clearance K122246 for MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12, Substantially Equivalent on 2012-08-13. Applicant: Celleration, Inc.. Device class: 2.
Clearance details
- Applicant
- Celleration, Inc.
- Product code
- Code NRB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4410
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eden Prairie, MN, US
Recent devices under product code NRB
view all- K162721 — Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- K140782 — ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
- K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
- K123980 — SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
- K112782 — MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
More clearances from Celleration, Inc.
view allAdverse events under product code NRB
product code NRB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.