Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K954488 |
Device Name |
ROLLER ELECTRODE |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 09/27/1995 |
Decision Date | 03/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|