Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K972471 |
Device Name |
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES |
Applicant |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
DEBORAH J CONNORS |
Correspondent |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
DEBORAH J CONNORS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/01/1997 |
Decision Date | 10/24/1997 |
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
|
|
|