| Device Classification Name |
Drain, Tee (Water Trap)
|
| 510(k) Number |
K897057 |
| Device Name |
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM |
| Applicant |
| Thayer Medical Corp. |
| 8141 E. Mclaren |
| P.O. Box 57907 |
|
Tucson,
AZ
85715
|
|
| Applicant Contact |
DAVID SLADEK |
| Correspondent |
| Thayer Medical Corp. |
| 8141 E. Mclaren |
| P.O. Box 57907 |
|
Tucson,
AZ
85715
|
|
| Correspondent Contact |
DAVID SLADEK |
| Regulation Number | 868.5995 |
| Classification Product Code |
|
| Date Received | 12/18/1989 |
| Decision Date | 03/16/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|