| Device Classification Name |
Endoscopic Irrigation/Suction System
|
| 510(k) Number |
K844691 |
| Device Name |
ENDOSCOPIC ASPIRATION CATHETER SET |
| Applicant |
| Jayco Pharmaceuticals |
| 895 Poplar Church Rd. |
|
Camp Hill,
PA
17011
|
|
| Applicant Contact |
LESTER J LIFTON |
| Correspondent |
| Jayco Pharmaceuticals |
| 895 Poplar Church Rd. |
|
Camp Hill,
PA
17011
|
|
| Correspondent Contact |
LESTER J LIFTON |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 12/03/1984 |
| Decision Date | 01/02/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|