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 K001329
Device Name INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
Applicant
LIFEMED OF CALIFORNIA
1216 SOUTH ALLEC ST.
ANAHEIM,  CA  92805 -6301
Applicant Contact PATRICIA BRINKER
Correspondent
LIFEMED OF CALIFORNIA
1216 SOUTH ALLEC ST.
ANAHEIM,  CA  92805 -6301
Correspondent Contact PATRICIA BRINKER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/27/2000
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-