Device Classification Name |
Microscope, Surgical
|
510(k) Number |
K812234 |
Device Name |
STORZ/OLYMPUS MICROSCOPE SYSTEM |
Applicant |
STORZ INSTRUMENT CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
STORZ INSTRUMENT CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4700
|
Classification Product Code |
|
Date Received | 08/11/1981 |
Decision Date | 09/11/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|