| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K813382 |
| Device Name |
DISPOSABLE ADULT ANES. CIRCUIT |
| Applicant |
| Intec. |
| 22200 E. 40 Hwy. |
|
Blue Springs,
MO
64015
|
|
| Applicant Contact |
J.W. Brown |
| Correspondent |
| Intec. |
| 22200 E. 40 Hwy. |
|
Blue Springs,
MO
64015
|
|
| Correspondent Contact |
J.W. Brown |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 12/02/1981 |
| Decision Date | 01/22/1982 |
| 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
|
|
|