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 K920382
Device Name FLEXICAIR LOW AIRLOSS THERAPY UNIT
Applicant
Support Systems Intl.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Support Systems Intl.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received01/30/1992
Decision Date 04/07/1992
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
-
-