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 K945588
Device Name DISPOSABLE 1CC SYRINGE WITH LUER LOCK
Applicant
Interventional Therapeutics Corp.
48668 Milmont Dr.
Fremont,  CA  94538
Applicant Contact LYNN K BELL
Correspondent
Interventional Therapeutics Corp.
48668 Milmont Dr.
Fremont,  CA  94538
Correspondent Contact LYNN K BELL
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/14/1994
Decision Date 02/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-