Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K112644 |
Device Name |
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM |
Applicant |
LOTUS BIO LTD |
461 MAIN STREET |
SUITE 217 |
PAWTUCKET,
RI
02860
|
|
Applicant Contact |
LORI KAHLER |
Correspondent |
LOTUS BIO LTD |
461 MAIN STREET |
SUITE 217 |
PAWTUCKET,
RI
02860
|
|
Correspondent Contact |
LORI KAHLER |
Regulation Number | 884.6160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/12/2011 |
Decision Date | 12/19/2012 |
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 |
No
|
|
|