• 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 Saline, Vascular Access Flush
510(k) Number K060339
Device Name KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
Applicant
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact BRIDGET GARDNER
Regulation Number880.5200
Classification Product Code
NGT  
Date Received02/10/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-