NOVOLET


Device Classification Name

set, administration, intravascular

510(k) Number K080665
Device Name NOVOLET
Applicant
U.S. SAFETY SYRINGES CO., INC.
1676 village green
crofton, 
MD 
21114

Applicant Contact christina smith
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 03/10/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No