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 Permanent Pacemaker Electrode
510(k) Number K850623
Device Name OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
Applicant
Oscor Medical Corp.
Kaye, Scholer, Fierman, Hays &
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact ALLEN M FOX
Correspondent
Oscor Medical Corp.
Kaye, Scholer, Fierman, Hays &
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact ALLEN M FOX
Regulation Number870.3680
Classification Product Code
DTB  
Date Received02/19/1985
Decision Date 04/19/1985
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
-
-