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 K953573
Device Name ICU STOPCOK WITH EXTENSION TUBING
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact RICHARD WATERS
Correspondent
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact RICHARD WATERS
Regulation Number880.5440
Classification Product Code
FMG  
Date Received07/31/1995
Decision Date 10/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-