Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Wound Cleaner, Ultrasound
510(k) Number K050129
Device Name CELLERATION MIST THERAPY SYSTEM 5.1
Applicant
Celleration, Inc.
10250 Valey View Rd.
Suite 137
Eden Prairie,  MN  55344
Applicant Contact DAVID BREMSETH
Correspondent
Celleration, Inc.
10250 Valey View Rd.
Suite 137
Eden Prairie,  MN  55344
Correspondent Contact DAVID BREMSETH
Regulation Number878.4410
Classification Product Code
NRB  
Date Received01/19/2005
Decision Date 05/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-