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, Antistick
510(k) Number K030976
Device Name CAREO RETRACTABLE SAFETY SYRINGE
Applicant
Life-Shield Products, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Life-Shield Products, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/28/2003
Decision Date 05/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-