Device Classification Name |
media, reproductive
|
510(k) Number |
K991378 |
Device Name |
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED |
Applicant |
SAGE BIOPHARMA |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GREG HOLLAND |
Correspondent |
SAGE BIOPHARMA |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GREG HOLLAND |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 04/21/1999 |
Decision Date | 09/24/1999 |
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
|
|
|