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 syringe, piston
510(k) Number K023271
Device Name TERUMO SYRINGE WITH/WITHOUT NEEDLE
Applicant
TERUMO MEDICAL CORP.
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact SANDI LARTKA
Correspondent
TERUMO MEDICAL CORP.
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact SANDI LARTKA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/01/2002
Decision Date 12/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-