• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name electrode, pacemaker, temporary
510(k) Number K980503
Device Name TEMPORARY CARDIAC PACING WIRE
Original Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville,  NJ  08876 0151
Original Contact gregory r jones
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/09/1998
Decision Date 04/10/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-