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 K151325
FOIA Releasable 510(k) K151325
Device Name Bovie J-Plasma Handpiece
Applicant
Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Brian Kunst
Correspondent
Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Brian Kunst
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/18/2015
Decision Date 08/04/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-