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 Restraint, Protective
510(k) Number K013239
Device Name COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
Applicant
Med Gen, Inc.
7284 W. Palmetto Pk. Rd.
Boca Raton,  FL  33433 -3406
Applicant Contact THEODORE BARASH
Correspondent
Med Gen, Inc.
7284 W. Palmetto Pk. Rd.
Boca Raton,  FL  33433 -3406
Correspondent Contact THEODORE BARASH
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/28/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-