Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K050650 |
Device Name |
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 |
Applicant |
CYTYC SURGICAL PRODUCTS |
1047 ELWELL CT. |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
JIM TALBOT |
Correspondent |
CYTYC SURGICAL PRODUCTS |
1047 ELWELL CT. |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
JIM TALBOT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/14/2005 |
Decision Date | 05/16/2005 |
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
|