| Device Classification Name |
Catheter And Tip, Suction
|
| 510(k) Number |
K913876 |
| Device Name |
ENDOTRACHEAL SUCTIONTUBE |
| Applicant |
| Willowtech |
| P.O. Box 185789 |
|
Fort Worth,
TX
76181
|
|
| Applicant Contact |
KEITH JUNG |
| Correspondent |
| Willowtech |
| P.O. Box 185789 |
|
Fort Worth,
TX
76181
|
|
| Correspondent Contact |
KEITH JUNG |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 08/29/1991 |
| Decision Date | 03/06/1992 |
| 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
|
|
|