Device Classification Name |
Media, Reproductive
|
510(k) Number |
K991391 |
Device Name |
PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF |
Applicant |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
3722 AVENUE SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GREG HOLLAND |
Correspondent |
ADVANCED REPRODUCTIVE TECHNOLOGIES |
3722 AVENUE SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GREG HOLLAND |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 04/21/1999 |
Decision Date | 01/10/2000 |
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
|
|
|