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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wound cleaner, ultrasound
510(k) Number K122246
Model CP-80023, CP-80024
Device Name MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
Original Applicant
CELLERATION, INC.
6321 bury drive, ste 15
eden prairie,  MN  55346
Original Contact kathy simpson
Regulation Number878.4410
Classification Product Code
NRB  
Date Received07/27/2012
Decision Date 08/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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