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 K031830
Device Name SAFEPRO PLUS SAFETY SYRINGE
Applicant
FORMOSA MEDICAL DEVICES, INC.
11497 COLUMBIA PARK DRIVE WEST
SUITE #9
JACKSONVILLE,  FL  32258
Applicant Contact JOSEPH J CHANG
Correspondent
FORMOSA MEDICAL DEVICES, INC.
11497 COLUMBIA PARK DRIVE WEST
SUITE #9
JACKSONVILLE,  FL  32258
Correspondent Contact JOSEPH J CHANG
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/13/2003
Decision Date 08/05/2003
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
-
-