Device Classification Name |
Device, External Penile Rigidity
|
510(k) Number |
K982275 |
Device Name |
RAPPORT V.T.D. |
Applicant |
Owen Mumford USA, Inc. |
849 PICKENS INDUSTRIAL DR. |
SUITE 14 |
MARIETTA,
GA
30062
|
|
Applicant Contact |
ROBERT SHAW |
Correspondent |
Owen Mumford USA, Inc. |
849 PICKENS INDUSTRIAL DR. |
SUITE 14 |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
ROBERT SHAW |
Regulation Number | 876.5020
|
Classification Product Code |
|
Date Received | 06/29/1998 |
Decision Date | 12/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|