Device Classification Name |
dilator, rectal
|
510(k) Number |
K894618 |
Device Name |
INAMED RHEMO-D (TM) DILATOR |
Applicant |
INAMED DEVELOPMENT CO. |
1035 A. CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
ELLEN DUKE |
Correspondent |
INAMED DEVELOPMENT CO. |
1035 A. CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
ELLEN DUKE |
Regulation Number | 876.5450
|
Classification Product Code |
|
Date Received | 07/20/1989 |
Decision Date | 01/18/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|