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 electrosurgical, cutting & coagulation & accessories
510(k) Number K042216
Device Name COOL-TIP RF ABLATION SYSTEM
Applicant
VALLEYLAB
5920 LONGBOW DR.
BOULDER,  CO  80301
Applicant Contact CHARLES COPPERBERG
Correspondent
VALLEYLAB
5920 LONGBOW DR.
BOULDER,  CO  80301
Correspondent Contact CHARLES COPPERBERG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/16/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-