Device Classification Name |
system, hypothermia, intravenous, cooling |
|||
---|---|---|---|---|
510(k) Number | K080899 | |||
Device Name | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | |||
Applicant |
|
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Applicant Contact | lynne aronson | |||
Correspondent |
|
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Correspodent Contact | lynne aronson | |||
Regulation Number | 870.5900 | |||
Classification Product Code |
|
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Date Received | 03/31/2008 | |||
Decision Date | 08/07/2008 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |