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 K852641
Device Name ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
Applicant
Sorin Biomedica, Fiat, USA, Inc.
Jeanne-Marie Varga
375 Park Ave.
New York,  NY  10152
Applicant Contact JEANNE-MARIE VARGA
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
Jeanne-Marie Varga
375 Park Ave.
New York,  NY  10152
Correspondent Contact JEANNE-MARIE VARGA
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/20/1985
Decision Date 01/14/1986
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
-
-