Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K944672 |
Device Name |
INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Applicant Contact |
SHERI D O'BRIEN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Correspondent Contact |
SHERI D O'BRIEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/22/1994 |
Decision Date | 12/06/1994 |
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
|