Device Classification Name |
Media, Reproductive
|
510(k) Number |
K003163 |
Device Name |
SYNVITRO FLUSH |
Applicant |
MEDICULT A/S |
P.O. BOX 262069 |
SAN DIEGO,
CA
92196 -2069
|
|
Applicant Contact |
RONALD G LEONARDI |
Correspondent |
MEDICULT A/S |
P.O. BOX 262069 |
SAN DIEGO,
CA
92196 -2069
|
|
Correspondent Contact |
RONALD G LEONARDI |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 10/10/2000 |
Decision Date | 03/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|