ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)


Device Classification Name

media, reproductive

510(k) Number K023033
Device Name ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
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 09/12/2002
Decision Date 11/26/2002
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