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 K033794
Device Name ULTICARE DISPOSABLE SYRINGE 3 ML/CC
Applicant
Ultimed, Inc.
188 Suquamish Way
Laconner,  WA  98257
Applicant Contact ELLEN G REDDING
Correspondent
Ultimed, Inc.
188 Suquamish Way
Laconner,  WA  98257
Correspondent Contact ELLEN G REDDING
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/05/2003
Decision Date 12/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-