Device Classification Name |
Obturator, For Endoscope
|
510(k) Number |
K001328 |
Device Name |
INTRODUCER SHEATH |
Applicant |
NOVASYS MEDICAL, INC. |
687 NO. PASTORIA AVE. |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
THOMAS C WEHMAN |
Correspondent |
NOVASYS MEDICAL, INC. |
687 NO. PASTORIA AVE. |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
THOMAS C WEHMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/26/2000 |
Decision Date | 07/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|