• 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 device, biofeedback
510(k) Number K092675
Device Name GRINDCARE
Applicant
MEDOTECH A/S
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Applicant Contact Calley Herzog
Correspondent
MEDOTECH A/S
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/01/2009
Decision Date 03/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-