• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name sleeve, limb, compressible
510(k) Number K120972
Device Name FLEXITOUCH SYSTEM
Original Applicant
TACTILE SYSTEMS TECHNOLOGY INC
1331 tyler st ne ste 200
minneapolis,  MN  55413
Original Contact phillip rose
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/02/2012
Decision Date 04/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-