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 Exerciser, Finger, Powered
510(k) Number K945803
Device Name THERMAFLEX, MODEL SD 55 C.P.M.H.
Applicant
Burke Neutech, Inc.
11701 S. Belcher Rd.
Suite 119
Largo,  FL  34643 -5117
Applicant Contact ROBERT E BURKE
Correspondent
Burke Neutech, Inc.
11701 S. Belcher Rd.
Suite 119
Largo,  FL  34643 -5117
Correspondent Contact ROBERT E BURKE
Regulation Number890.5410
Classification Product Code
JFA  
Subsequent Product Code
IRT  
Date Received11/28/1994
Decision Date 05/11/1995
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
-
-