Device Classification Name |
needle, fistula
|
510(k) Number |
K932074 |
Device Name |
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD |
Applicant |
MEDISYSTEMS CORP. |
THREE EMBARCADERO CENTER |
11TH FLOOR |
SAN FRANCISCO,
CA
94111
|
|
Applicant Contact |
ALAN C HINTON |
Correspondent |
MEDISYSTEMS CORP. |
THREE EMBARCADERO CENTER |
11TH FLOOR |
SAN FRANCISCO,
CA
94111
|
|
Correspondent Contact |
ALAN C HINTON |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 04/28/1993 |
Decision Date | 02/18/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|