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 Pad, Heating, Powered
510(k) Number K160943
Device Name Bite Away
Applicant
Riemser Pharma
An der Wiek 7
Greifswald-Insel Riems,  DE D-17493
Applicant Contact Ronny Raasch
Correspondent
Quality Systems Resources (QSR)
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number890.5740
Classification Product Code
IRT  
Date Received04/05/2016
Decision Date 08/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-