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 Bed, Flotation Therapy, Powered
510(k) Number K921768
Device Name HAZEL II
Applicant
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Applicant Contact WILLIAM H QUIRK
Correspondent
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Correspondent Contact WILLIAM H QUIRK
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received04/14/1992
Decision Date 04/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-