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 System, Thermal Regulating
510(k) Number K171149
Device Name Altrix Temperature Management Wraps
Applicant
Stryker Medical
3800 East Centre Avenue
Portage,  MI  49002
Applicant Contact Brian Orwat
Correspondent
Stryker Medical
3800 East Centre Avenue
Portage,  MI  49002
Correspondent Contact Brian Orwat
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/19/2017
Decision Date 07/18/2017
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
-
-