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 Set, Administration, Intravascular
510(k) Number K945298
Device Name SMARTFLOW I ADMINISTRATION SET
Applicant
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Applicant Contact MARK SHANNON
Correspondent
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Correspondent Contact MARK SHANNON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/31/1994
Decision Date 06/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-