SAFEPRO SAFETY SYRINGE


Device Classification Name

syringe, antistick

510(k) Number K022063
Device Name SAFEPRO SAFETY SYRINGE
Original Applicant
FORMOSA MEDICAL DEVICES, INC.
11497 columbia park drive west
suite #9
jacksonville, 
FL 
32258

Original Contact joseph j chang
Regulation Number 880.5860
Classification Product Code
MEG  
Date Received 06/25/2002
Decision Date 08/29/2002
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