SURE-LOK


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K021315
Device Name SURE-LOK
Original Applicant
VITAL SIGNS, INC.
11039 east lansing circle
englewood, 
CO 
80112

Original Contact thomas w dielmann
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 04/25/2002
Decision Date 08/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No