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 Needle, Fistula
510(k) Number K040247
Device Name PLUME SAFETY AVF NEEDLE
Applicant
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Applicant Contact CHONG SWEE CHEAU
Correspondent
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Correspondent Contact CHONG SWEE CHEAU
Regulation Number876.5540
Classification Product Code
FIE  
Subsequent Product Code
FOZ  
Date Received02/03/2004
Decision Date 03/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-