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 K854997
Device Name IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
Applicant
Telectronics, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
Telectronics, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number870.3620
Classification Product Code
DTD  
Date Received12/12/1985
Decision Date 02/12/1986
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
-
-