Device Classification Name |
Media, Reproductive
|
510(k) Number |
K142991 |
Device Name |
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA |
Applicant |
LifeGlobal Group, LLC |
393 Soundview Road |
Guilford,
CT
06437
|
|
Applicant Contact |
Michael D. Cecchi |
Correspondent |
LifeGlobal Group, LLC |
393 Soundview Road |
Guilford,
CT
06437
|
|
Correspondent Contact |
Michael D. Cecchi |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 10/16/2014 |
Decision Date | 02/17/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|