Device Classification Name |
catheter (gastric, colonic, etc.), irrigation and aspiration
|
510(k) Number |
K770534 |
Device Name |
THERAPEUTIC APPARATUS, DIERKER TYPE |
Applicant |
WELL BEING ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WELL BEING ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/21/1977 |
Decision Date | 04/21/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|