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 Apparatus, Vestibular Analysis
510(k) Number K070676
Device Name KOREBALANCE (KINESTHETIC ABILITY TRAINER)
Applicant
SPORTKAT, LLC
1497 POINSETTIA AVE. STE. 157
VISTA,  CA  92083
Applicant Contact DAMON R LAWSON
Correspondent
SPORTKAT, LLC
1497 POINSETTIA AVE. STE. 157
VISTA,  CA  92083
Correspondent Contact DAMON R LAWSON
Classification Product Code
LXV  
Date Received03/12/2007
Decision Date 04/18/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-