Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K941250 |
Device Name |
TROCAR AND CANNULA |
Applicant |
DEBUSK TECHNOLOGY CORP. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Applicant Contact |
DEBRA F MANNING |
Correspondent |
DEBUSK TECHNOLOGY CORP. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Correspondent Contact |
DEBRA F MANNING |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/15/1994 |
Decision Date | 05/06/1994 |
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
|
|
|