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 apparatus, electrosurgical
510(k) Number K945861
Device Name BERGEN 710 ESU
Applicant
BERGEN MFG.
9345 ROOKERY RD.
NEWPORT RICHEY,  FL  34654
Applicant Contact ROGER OOSTEN
Correspondent
BERGEN MFG.
9345 ROOKERY RD.
NEWPORT RICHEY,  FL  34654
Correspondent Contact ROGER OOSTEN
Regulation Number878.4400
Classification Product Code
HAM  
Date Received12/01/1994
Decision Date 03/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-