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 Device, Acupressure
510(k) Number K053509
Device Name ACUBAND ACUPRESSURE WRIST BAND DEVICE
Applicant
Acuband, Inc.
101 Little Silver Point Rd.
Little Silver,  NJ  07739
Applicant Contact RICHARD GRIFFITH
Correspondent
Acuband, Inc.
101 Little Silver Point Rd.
Little Silver,  NJ  07739
Correspondent Contact RICHARD GRIFFITH
Classification Product Code
MVV  
Date Received12/16/2005
Decision Date 08/16/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-