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 Implantable Pacemaker Pulse-Generator
510(k) Number K884733
Device Name AFP MODEL 262T PULSE GENERATOR
Applicant
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Applicant Contact RITA BROWN
Correspondent
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Correspondent Contact RITA BROWN
Regulation Number870.3610
Classification Product Code
DXY  
Date Received11/10/1988
Decision Date 02/10/1989
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
-
-