SUNIVF DISHES


Device Classification Name

labware, assisted reproduction

510(k) Number K080395
Device Name SUNIVF DISHES
Applicant
INTL., INC.
393 soundview rd.
guilford, 
CT 
06437

Applicant Contact michael d cecchi
Correspondent
INTL., INC.
393 soundview rd.
guilford, 
CT 
06437

Correspodent Contact michael d cecchi
Regulation Number 884.6160
Classification Product Code
MQK  
Date Received 02/13/2008
Decision Date 08/13/2008
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