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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
Device Name MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
Applicant
Celleration, Inc.
6321 Bury Dr., Suite 15
Eden Prairie,  MN  55346
Applicant Contact KATHY SIMPSON
Correspondent
Celleration, Inc.
6321 Bury Dr., Suite 15
Eden Prairie,  MN  55346
Correspondent Contact KATHY SIMPSON
Regulation Number878.4410
Classification Product Code
NRB  
Date Received07/27/2012
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
Predetermined Change
Control Plan Authorized		 No
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