Device Classification Name |
accessory to continuous ventilator (respirator)
|
510(k) Number |
K010401 |
Device Name |
TRI-PLEX ADAPTER |
Applicant |
THE MEDICAL DEVICE GROUP, INC. |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
THE MEDICAL DEVICE GROUP, INC. |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 10/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|