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 Sleeve, Limb, Compressible
510(k) Number K170415
Device Name Medline Hemo-Force DVT Compression Sleeve
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Matt Clausen
Correspondent
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Matt Clausen
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/10/2017
Decision Date 09/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-