SYREX PRE-FILLED SYRINGE


Device Classification Name

heparin, vascular access flush

510(k) Number K023740
Device Name SYREX PRE-FILLED SYRINGE
Original Applicant
EXCELSIOR MEDICAL CORP.
1923 heck ave.
neptune, 
NJ 
07753

Original Contact david lumia
Regulation Number 880.5200
Classification Product Code
NZW  
Date Received 11/07/2002
Decision Date 05/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

Yes