Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K073702 |
Device Name |
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR |
Applicant |
LAZARUS MEDICAL LLC |
2129 BENEVENTUM CT |
RALEIGH,
NC
27606
|
|
Applicant Contact |
CYNTHIA J.M NOLTE |
Correspondent |
LAZARUS MEDICAL LLC |
2129 BENEVENTUM CT |
RALEIGH,
NC
27606
|
|
Correspondent Contact |
CYNTHIA J.M NOLTE |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 12/31/2007 |
Decision Date | 06/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|