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 Automated External Defibrillators (Non-Wearable)
510(k) Number K960329
Device Name DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
Applicant
Contour Medical Technology, Inc.
144 Bain St.
Lavergne,  TN  37086
Applicant Contact JOSH TRANTUM
Correspondent
Contour Medical Technology, Inc.
144 Bain St.
Lavergne,  TN  37086
Correspondent Contact JOSH TRANTUM
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received01/24/1996
Decision Date 07/02/1996
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
Recalls CDRH Recalls
-
-