• 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 arthrometer
510(k) Number K881876
Device Name DYNAMIC CRUCIATE TESTER
Applicant
DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact KENNETH E CARRIER
Correspondent
DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact KENNETH E CARRIER
Regulation Number890.1615
Classification Product Code
LYH  
Date Received05/04/1988
Decision Date 11/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-