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 K102737
Device Name KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Applicant
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact MELODY BI
Correspondent
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact MELODY BI
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/22/2010
Decision Date 10/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-