• 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 Camera, Television, Microsurgical, Without Audio
510(k) Number K862034
Device Name JEDMED CCD-02 VIDEO CAMERA SYSTEM
Applicant
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number878.4160
Classification Product Code
FWD  
Date Received05/29/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-