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 pump, portable, aspiration (manual or powered)
510(k) Number K013116
Device Name DURQ/ QUALIDURA
Applicant
EVER-SAFETY TECHNICAL SERVICE
NO 13 ALLEY 28 LANE 108
YOUNG FENG RD
TAICHUNG HSIEN, TAIWAN,  CN
Applicant Contact DANIEL YANG
Correspondent
EVER-SAFETY TECHNICAL SERVICE
NO 13 ALLEY 28 LANE 108
YOUNG FENG RD
TAICHUNG HSIEN, TAIWAN,  CN
Correspondent Contact DANIEL YANG
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/18/2001
Decision Date 01/18/2002
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
-
-