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 electrode, electrosurgical, active, urological
510(k) Number K091511
Device Name MODERN MEDICAL RESECTOSCOPE ELECTRODES
Applicant
MODERN MEDICAL EQUIPMENT MFG., LTD.
35 TAI LIN PAI RD.
KWAI CHUNG, HONG KONG,  CN
Applicant Contact EUGENE YEUNG
Correspondent
MODERN MEDICAL EQUIPMENT MFG., LTD.
35 TAI LIN PAI RD.
KWAI CHUNG, HONG KONG,  CN
Correspondent Contact EUGENE YEUNG
Regulation Number876.4300
Classification Product Code
FAS  
Date Received05/22/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-