ALLGRAD 45 AND 90 CELL SEPARATION MEDIA


Device Classification Name

media, reproductive

510(k) Number K022330
Device Name ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
Original Applicant
INTL., INC.
393 soundview rd.
guilford, 
CT 
06443

Original Contact michael d cecchi
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 07/18/2002
Decision Date 08/26/2002
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