MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP


Device Classification Name

pump, breast, powered

510(k) Number K081463
Device Name MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
Applicant
MEDEL S.P.A.
112 cavistion way
cary, 
NC 
27519

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

Correspodent Contact terrence o’brien
Regulation Number 884.5160
Classification Product Code
HGX  
Date Received 05/23/2008
Decision Date 02/06/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No