Device Classification Name |
catheter, peritoneal, long-term indwelling
|
510(k) Number |
K813488 |
Device Name |
CATHETER REGULAR |
Applicant |
ACCURATE SURGICAL INSTRUMENTS CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ACCURATE SURGICAL INSTRUMENTS CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 12/01/1981 |
Decision Date | 12/31/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|