| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K924889 |
| Device Name |
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT |
| Applicant |
| Zefon Medical Products |
| 5350 Southwest First Ln. |
|
Ocala,
FL
34474
|
|
| Applicant Contact |
JOSEPH BOZOSI |
| Correspondent |
| Zefon Medical Products |
| 5350 Southwest First Ln. |
|
Ocala,
FL
34474
|
|
| Correspondent Contact |
JOSEPH BOZOSI |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 09/28/1992 |
| Decision Date | 03/19/1993 |
| 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
|
|
|