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 Electrode, Pacemaker, Temporary
510(k) Number K861403
Device Name TB SERIES BIPOLAR PACING LEADS
Applicant
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Applicant Contact DE GRAAD
Correspondent
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Correspondent Contact DE GRAAD
Regulation Number870.3680
Classification Product Code
LDF  
Date Received04/15/1986
Decision Date 06/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-