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 stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K182267
Device Name PAT (Pain Alleviation Technologies)
Applicant
Marchan Medical, LLC
165 S Ashe St.
Southern Pines,  NC  28387
Applicant Contact Mark Chandler
Correspondent
Marchan Medical, LLC
165 S Ashe St.
Southern Pines,  NC  28387
Correspondent Contact Mark Chandler
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/21/2018
Decision Date 02/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-