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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 K140782
Device Name ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
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 Received03/31/2014
Decision Date 08/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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