Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K962193 |
Device Name |
PORTLAND TROCARS |
Applicant |
SURGICAL INNOVATIONS PLC |
1070 THORNWOOD LN. |
DACULA,
GA
30211 -3007
|
|
Applicant Contact |
MICHAEL A CLARK |
Correspondent |
SURGICAL INNOVATIONS PLC |
1070 THORNWOOD LN. |
DACULA,
GA
30211 -3007
|
|
Correspondent Contact |
MICHAEL A CLARK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/07/1996 |
Decision Date | 08/28/1996 |
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
|
|
|