Device Classification Name |
Needle, Fistula
|
510(k) Number |
K903440 |
Device Name |
VIVAMED FISTULA NEEDLE |
Applicant |
S.S. ENT. |
S&S ASSOCIATES |
34 RAVENWOOD DRIVE |
WESTON,
CT
06883
|
|
Applicant Contact |
KEVIN SZOGAS |
Correspondent |
S.S. ENT. |
S&S ASSOCIATES |
34 RAVENWOOD DRIVE |
WESTON,
CT
06883
|
|
Correspondent Contact |
KEVIN SZOGAS |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 04/20/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|