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 stopcock, i.v. set
510(k) Number K070143
Device Name JMS PLANECTA STOPCOCK
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 Number880.5440
Classification Product Code
FMG  
Date Received01/16/2007
Decision Date 04/10/2007
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
-
-