Device Classification Name |
evacuator, gastro-urology
|
510(k) Number |
K801781 |
Device Name |
CATHETER IRRIGATION SYRINGES, #3100,3110 |
Applicant |
THE HEALTHCARE GROUP LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
THE HEALTHCARE GROUP LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.4370
|
Classification Product Code |
|
Date Received | 07/28/1980 |
Decision Date | 08/13/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|