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 K061417
Device Name GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
Applicant
Genicon
6869 Stapoint Ct.
Suite 114
Winter Park,  FL  32792
Applicant Contact GARY HABERLAND
Correspondent
Genicon
6869 Stapoint Ct.
Suite 114
Winter Park,  FL  32792
Correspondent Contact GARY HABERLAND
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/22/2006
Decision Date 10/10/2006
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
-
-