Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K112915 |
Device Name |
SPIRTIUS CUFF INFLATION SYRINGE |
Applicant |
SPIRITUS TECHNOLOGIES LLC |
12005 W. 100TH TERRACE |
LENEXA,
KS
66215
|
|
Applicant Contact |
BRANDON W CLOSE |
Correspondent |
SPIRITUS TECHNOLOGIES LLC |
12005 W. 100TH TERRACE |
LENEXA,
KS
66215
|
|
Correspondent Contact |
BRANDON W CLOSE |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 05/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|