| Device Classification Name |
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
|
| 510(k) Number |
K971022 |
| Device Name |
CHASE SUCKER |
| Applicant |
| Chase Medical, Inc. |
| 1876 Firman Dr. |
|
Richardson,
TX
75081
|
|
| Applicant Contact |
BERT DAVIS |
| Correspondent |
| Chase Medical, Inc. |
| 1876 Firman Dr. |
|
Richardson,
TX
75081
|
|
| Correspondent Contact |
BERT DAVIS |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 03/20/1997 |
| Decision Date | 04/17/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|