Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K090777 |
Device Name |
EZC MEDICAL, LLC INTUBAIDFLEX |
Applicant |
EZC MEDICAL, LLC |
16 A FUNSTON AVENUE |
SAN FRANCISCO,
CA
94129
|
|
Applicant Contact |
PAVAN SETHI |
Correspondent |
EZC MEDICAL, LLC |
16 A FUNSTON AVENUE |
SAN FRANCISCO,
CA
94129
|
|
Correspondent Contact |
PAVAN SETHI |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 03/23/2009 |
Decision Date | 08/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|