• 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 K121962
Device Name PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
Original Applicant
MEGO AFEK AC LTD
kibbutz afek
afek,  IL 30042
Original Contact alex rapel
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/05/2012
Decision Date 10/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-