CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES


Device Classification Name

accessory, assisted reproduction

510(k) Number K030525
Device Name CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
Applicant
MID-ATLANTIC DIAGNOSTICS, INC.
438 north elmwood rd.
marlton, 
NJ 
08053

Applicant Contact susan j bush
Correspondent
MID-ATLANTIC DIAGNOSTICS, INC.
438 north elmwood rd.
marlton, 
NJ 
08053

Correspodent Contact susan j bush
Regulation Number 884.6120
Classification Product Code
MQG  
Date Received 02/19/2003
Decision Date 08/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No