| Device Classification Name |
Circuit, Breathing (W Connector, Adaptor, Y Piece)
|
| 510(k) Number |
K925893 |
| Device Name |
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT |
| Applicant |
| Oem Medical Div. |
| 8741 Landmark Rd. |
| P.O. Box 27604 |
|
Richmond,
VA
23228
|
|
| Applicant Contact |
JERRY W SCHEIB |
| Correspondent |
| Oem Medical Div. |
| 8741 Landmark Rd. |
| P.O. Box 27604 |
|
Richmond,
VA
23228
|
|
| Correspondent Contact |
JERRY W SCHEIB |
| Regulation Number | 868.5240 |
| Classification Product Code |
|
| Date Received | 11/17/1992 |
| Decision Date | 03/12/1993 |
| 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
|
|
|