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 K193476
Device Name VariLymph 12 pro
Applicant
Slk Medical GmbH
Oberste-Wilms-Str. 15a
Dortmund,  DE 44309
Applicant Contact Matthew Reid
Correspondent
Slk Medical GmbH
Oberste-Wilms-Str. 15a
Dortmund,  DE 44309
Correspondent Contact Matthew Reid
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/16/2019
Decision Date 08/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-