Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K120278 |
Device Name |
WIRELESS IMAGE TRANSMITTER UNIT |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY |
P.O. BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
SHERI MUSGNUNG |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY |
P.O. BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
SHERI MUSGNUNG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/30/2012 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|