HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)


Device Classification Name

media, reproductive

510(k) Number K022352
Device Name HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
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 07/19/2002
Decision Date 08/28/2002
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