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 K972814
Device Name LOCATOR MODEL 4036
Applicant
Pacesetter, Inc.
15900 Valley View Ct.
P O Box 9221
Sylmar,  CA  91342
Applicant Contact BETTY M JOHNSON
Correspondent
Pacesetter, Inc.
15900 Valley View Ct.
P O Box 9221
Sylmar,  CA  91342
Correspondent Contact BETTY M JOHNSON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received07/29/1997
Decision Date 02/23/1998
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-