Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K945394 |
Device Name |
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER |
Applicant |
INNOVATIVE SURGICAL, INC. |
3071 CONTINENTAL DR., |
SUITE 102 |
WEST PALM BEACH,
FL
33407
|
|
Applicant Contact |
MARK C HAMBLIN |
Correspondent |
INNOVATIVE SURGICAL, INC. |
3071 CONTINENTAL DR., |
SUITE 102 |
WEST PALM BEACH,
FL
33407
|
|
Correspondent Contact |
MARK C HAMBLIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/03/1994 |
Decision Date | 01/27/1995 |
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
|
|
|