Device Classification Name |
set, administration, intravascular |
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---|---|---|---|---|
510(k) Number | K991985 | |||
Device Name | COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET | |||
Applicant |
|
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Applicant Contact | april lavender | |||
Correspondent |
|
|||
Correspodent Contact | april lavender | |||
Regulation Number | 880.5440 | |||
Classification Product Code |
|
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Date Received | 06/14/1999 | |||
Decision Date | 08/20/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |