Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K050209 |
Device Name |
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM |
Applicant |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
JANICE HASELTON |
Correspondent |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JANICE HASELTON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/28/2005 |
Decision Date | 11/23/2005 |
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
|
|
|