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 Dilator, Vessel, Surgical
510(k) Number K960312
Device Name RDI CARDIAC INSULATION PAD
Applicant
R D Intl.
304 Arborcrest
Richardson,  TX  75080
Applicant Contact MIKE DAVIS
Correspondent
R D Intl.
304 Arborcrest
Richardson,  TX  75080
Correspondent Contact MIKE DAVIS
Regulation Number870.4475
Classification Product Code
DWP  
Date Received01/22/1996
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
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
-
-