| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K926454 |
| Device Name |
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON |
| Applicant |
| Medical, Inc. |
| 1290 Sanchez St. |
| Suite #2 |
|
San Francisco,
CA
94114
|
|
| Applicant Contact |
DENNIS REAGER |
| Correspondent |
| Medical, Inc. |
| 1290 Sanchez St. |
| Suite #2 |
|
San Francisco,
CA
94114
|
|
| Correspondent Contact |
DENNIS REAGER |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 12/24/1992 |
| Decision Date | 06/22/1993 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|