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 K941244
Device Name SAFELINE SYSTEM TURN LOCK CANNULA
Applicant
MCGAW, INC.
2525 MCGAW AVE.
IRVINE,  CA  92714 -5895
Applicant Contact JOHN G D'ANGELO
Correspondent
MCGAW, INC.
2525 MCGAW AVE.
IRVINE,  CA  92714 -5895
Correspondent Contact JOHN G D'ANGELO
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received03/15/1994
Decision Date 11/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-