LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES


Device Classification Name

media, reproductive

510(k) Number K112083
Device Name LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
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 884.6180
Classification Product Code
MQL  
Date Received 07/21/2011
Decision Date 05/03/2012
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

Yes