Device Classification Name |
Media, Reproductive
|
510(k) Number |
K061145 |
FOIA Releasable 510(k) |
K061145
|
Device Name |
SPERMSLOW |
Applicant |
MEDICULT A/S |
9915 CAM. CHIRIMOLLA |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
RONALD G LEONARDI |
Correspondent |
MEDICULT A/S |
9915 CAM. CHIRIMOLLA |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
RONALD G LEONARDI |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 04/25/2006 |
Decision Date | 10/02/2006 |
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 |
Yes
|
|
|