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 K853034
Device Name #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
Applicant
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Applicant Contact LISA S JONES
Correspondent
INTERMEDICS, INC.
P.O. BOX 617
FREEPORT,  TX  77541 -0617
Correspondent Contact LISA S JONES
Regulation Number870.3610
Classification Product Code
DXY  
Date Received07/18/1985
Decision Date 07/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-