MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12— 510(k) K122246

Substantially Equivalent

Celleration, 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..

Clearance details

Applicant: Celleration, Inc.
Product code: Code NRB
Advisory panel: General, Plastic Surgery
Date received: 2012-07-27
Decision date: 2012-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

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Adverse events under product code NRB

product code NRB

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.