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 K933418
Device Name HAND THERAPY ASSOST
Applicant
Bardon Ent., Inc.
313 Orange Plank Rd.
Hampton,  VA  23669
Applicant Contact DONALD E BARTHLOME
Correspondent
Bardon Ent., Inc.
313 Orange Plank Rd.
Hampton,  VA  23669
Correspondent Contact DONALD E BARTHLOME
Regulation Number890.5410
Classification Product Code
JFA  
Date Received07/13/1993
Decision Date 04/28/1994
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
-
-