• 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 Needle, Hypodermic, Single Lumen
510(k) Number K103587
Device Name DISPOSABLE BLLOD COLLECTION NEEDLE
Applicant
WEIHAI HONGYU MEDICAL DEVICES CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 264200
Applicant Contact Diana Hong
Correspondent
WEIHAI HONGYU MEDICAL DEVICES CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 264200
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/07/2010
Decision Date 04/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-