Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K944309 |
Device Name |
M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM |
Applicant |
M.E.R. SURGICAL CO. |
773 TROTTER COURT |
WALNUT,
CA
91789
|
|
Applicant Contact |
WILLIAM MEYER |
Correspondent |
M.E.R. SURGICAL CO. |
773 TROTTER COURT |
WALNUT,
CA
91789
|
|
Correspondent Contact |
WILLIAM MEYER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/02/1994 |
Decision Date | 04/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|