Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K120079 |
Device Name |
PRIMED TRACHEOSTOMY TUBES (MULTIPLE) |
Applicant |
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH |
STRASSE DES 20. JULI NR.1 |
HALBERSTADT,
DE
38820
|
|
Applicant Contact |
ALEXANDRA SINGER |
Correspondent |
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH |
STRASSE DES 20. JULI NR.1 |
HALBERSTADT,
DE
38820
|
|
Correspondent Contact |
ALEXANDRA SINGER |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 01/10/2012 |
Decision Date | 05/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|