Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K010489 |
Device Name |
DYONICS VISION 111 MOBILE VIDEO UNIT |
Applicant |
SMITH & NEPHEW, INC. |
3600 NW 138TH ST. |
OKLAHOMA CITY,
OK
73134
|
|
Applicant Contact |
STEVEN JACKSON |
Correspondent |
SMITH & NEPHEW, INC. |
3600 NW 138TH ST. |
OKLAHOMA CITY,
OK
73134
|
|
Correspondent Contact |
STEVEN JACKSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/20/2001 |
Decision Date | 04/10/2001 |
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
|
|
|