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 Pacemaker Lead Adaptor
510(k) Number K912773
Device Name UNIPOLAR UPSIZING ADAPTOR
Applicant
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3620
Classification Product Code
DTD  
Date Received06/24/1991
Decision Date 10/23/1991
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
-
-