Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K011944 |
Device Name |
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 |
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 | 06/21/2001 |
Decision Date | 09/19/2001 |
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
|
|
|