| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K911736 |
| Device Name |
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT |
| Applicant |
| Medical Assemblies, Inc. |
| 2002 W. Vernal Pike |
|
Bloomington,
IN
47404
|
|
| Applicant Contact |
GREG POPP |
| Correspondent |
| Medical Assemblies, Inc. |
| 2002 W. Vernal Pike |
|
Bloomington,
IN
47404
|
|
| Correspondent Contact |
GREG POPP |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 04/17/1991 |
| Decision Date | 07/11/1991 |
| 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
|
|
|