| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K891479 |
| Device Name |
DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS |
| Applicant |
| Anetec, Inc. |
| P.O. Box 991, 340 Bell Blvd. |
| Belleville, Ontario |
|
K8n 5b6,
CA
|
|
| Applicant Contact |
CATHARINE P HUFF |
| Correspondent |
| Anetec, Inc. |
| P.O. Box 991, 340 Bell Blvd. |
| Belleville, Ontario |
|
K8n 5b6,
CA
|
|
| Correspondent Contact |
CATHARINE P HUFF |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 03/16/1989 |
| Decision Date | 05/05/1989 |
| 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
|
|
|