Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K950500 |
Device Name |
BASIC REUSABLE TROCAR SYSTEM |
Applicant |
ENDOSCOPIC CONCEPTS, INC. |
3085 INGLEWOOD TERRACE |
BOCA RATON,
FL
33431
|
|
Applicant Contact |
J. A WILSON |
Correspondent |
ENDOSCOPIC CONCEPTS, INC. |
3085 INGLEWOOD TERRACE |
BOCA RATON,
FL
33431
|
|
Correspondent Contact |
J. A WILSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/06/1995 |
Decision Date | 02/23/1995 |
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
|
|
|