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 K071424
Device Name PMAX NEWTRON XS
Applicant
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact STEVE SALESKY
Correspondent
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact STEVE SALESKY
Regulation Number872.4850
Classification Product Code
ELC  
Date Received05/23/2007
Decision Date 08/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-