AG-CLASSIC


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K072494
Device Name AG-CLASSIC
Applicant
MEDEL S.P.A.
112 cavistion way
cary, 
NC 
27519

Applicant Contact terrance m o’brien
Correspondent
MEDEL S.P.A.
112 cavistion way
cary, 
NC 
27519

Correspodent Contact terrance m o’brien
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 09/05/2007
Decision Date 02/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No