Device Classification Name |
Clamp, Line
|
510(k) Number |
K802009 |
Device Name |
FLOWCLAMP CAT.#1011 & 1012 |
Applicant |
POLLAK (INTL.), LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
POLLAK (INTL.), LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 08/20/1980 |
Decision Date | 10/31/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|