Device Classification Name |
ventilator, continuous, facility use |
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---|---|---|---|---|
510(k) Number | K032922 | |||
Device Name | CLARISSA INFANT NCPAP CANNULA | |||
Applicant |
|
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Applicant Contact | richard j larkin | |||
Correspondent |
|
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Correspodent Contact | richard j larkin | |||
Regulation Number | 868.5895 | |||
Classification Product Code |
|
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Date Received | 09/22/2003 | |||
Decision Date | 09/22/2004 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
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510k Review Panel |
Anesthesiology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |