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 K874579
Device Name COEUR CONTROL SYRINGE
Applicant
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Applicant Contact S DENSMORE
Correspondent
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Correspondent Contact S DENSMORE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/06/1987
Decision Date 01/19/1988
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
-
-