MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12


Device Classification Name

wound cleaner, ultrasound

510(k) Number K122246
Device Name MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
Applicant
CELLERATION, INC.
6321 bury drive, ste 15
eden prairie, 
MN 
55346

Applicant Contact kathy simpson
Correspondent
CELLERATION, INC.
6321 bury drive, ste 15
eden prairie, 
MN 
55346

Correspodent Contact kathy simpson
Regulation Number 878.4410
Classification Product Code
NRB  
Date Received 07/27/2012
Decision Date 08/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No