Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K950042 |
Device Name |
SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER |
Applicant |
ACCURATE SURGICAL INSTRUMENTS CO. |
590 RICHMOND STREET WEST |
TORONTO CANADO M5V 1Y9,
CA
M5V 1Y9
|
|
Applicant Contact |
D ROTHMAN |
Correspondent |
ACCURATE SURGICAL INSTRUMENTS CO. |
590 RICHMOND STREET WEST |
TORONTO CANADO M5V 1Y9,
CA
M5V 1Y9
|
|
Correspondent Contact |
D ROTHMAN |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 01/05/1995 |
Decision Date | 12/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|