Device Classification Name |
tube, tracheostomy (w/wo connector) |
|||
---|---|---|---|---|
510(k) Number | K050379 | |||
Device Name | CS MEDICAL ADULT TTCF CATHETER | |||
Applicant |
|
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Applicant Contact | lewis ward | |||
Correspondent |
|
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Correspodent Contact | lewis ward | |||
Regulation Number | 868.5800 | |||
Classification Product Code |
|
|||
Date Received | 02/15/2005 | |||
Decision Date | 07/12/2005 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
|||
510k Review Panel |
Anesthesiology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |