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 K021473
FOIA Releasable 510(k) K021473
Device Name BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
Applicant
Augustine Medical, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact SCOTT D AUGUSTINE
Correspondent
Augustine Medical, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact SCOTT D AUGUSTINE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/08/2002
Decision Date 07/09/2002
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
-
-