VITRIFICATION KIT & VITRIFICATION WARMING KIT


Device Classification Name

media, reproductive

510(k) Number K073522
Device Name VITRIFICATION KIT & VITRIFICATION WARMING KIT
Applicant
SAGE IN-VITRO FERTILIZATION INC.
3722 ave. sausalito
irvine, 
CA 
92606

Applicant Contact grace holland
Correspondent
SAGE IN-VITRO FERTILIZATION INC.
3722 ave. sausalito
irvine, 
CA 
92606

Correspodent Contact grace holland
Regulation Number 884.6180
Classification Product Code
MQL  
Date Received 12/14/2007
Decision Date 10/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes