• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121262
Models MIS-1171; MIS-1172, MIS-1177, MIS-1173; MIS-1175, MIS-1183, MIS-1185; MIS-1180
Device Name MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
Original Applicant
MEDEFIL, INC.
250 windy point dr.
glendale heights,  IL  60139
Original Contact pradeep aggarwal
Regulation Number880.5200
Classification Product Code
NGT  
Date Received04/26/2012
Decision Date 09/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-