Device Classification Name |
nebulizer (direct patient interface) |
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---|---|---|---|---|
510(k) Number | K021443 | |||
Device Name | 56 SERIES JET NEBULIZER | |||
Original Applicant |
|
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Original Contact | terry o’brien | |||
Regulation Number | 868.5630 | |||
Classification Product Code |
|
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Date Received | 05/06/2002 | |||
Decision Date | 10/21/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
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510k Review Panel |
Anesthesiology |
|||
statement |
statement |
|||
Type | Abbreviated | |||
Reviewed by Third Party | No | |||
Combination Product |
No |