• 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 stocking, medical support (to prevent pooling of blood in legs)
510(k) Number K122485
Device Name ENCIRCLE COMPRESSION THERAPY STOCKING
Original Applicant
ENCIRCLE MEDICAL DEVICES LTD.
2400 via carillo
palos verdes estates,  CA  90274
Original Contact sigi caron
Regulation Number880.5780
Classification Product Code
DWL  
Date Received08/14/2012
Decision Date 04/23/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-