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 K021080
Device Name NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
Applicant
Cardio Med Supplies, Inc.
5 Gormley Industrial Ave.
Gormley, Ontario,  CA L0H 1G0
Applicant Contact DONNA MCCOMB
Correspondent
Cardio Med Supplies, Inc.
5 Gormley Industrial Ave.
Gormley, Ontario,  CA L0H 1G0
Correspondent Contact DONNA MCCOMB
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received04/03/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-