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 Scaler, Ultrasonic
510(k) Number K130693
Device Name AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
Applicant
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Applicant Contact CHERIE TREGONING
Correspondent
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Correspondent Contact CHERIE TREGONING
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Codes
EIA   EKX  
Date Received03/14/2013
Decision Date 08/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-