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Stockert S5 Gas Blender Manual
Device Classification Name | console, heart-lung machine, cardiopulmonary bypass | |||
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510(k) Number | K080832 | |||
Device Name | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | |||
Applicant |
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Applicant Contact | rosina robinson | |||
Correspondent |
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Correspodent Contact | rosina robinson | |||
Regulation Number | 870.4220 | |||
Classification Product Code |
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Date Received | 03/25/2008 | |||
Decision Date | 07/30/2008 | |||
Decision | substantially equivalent (SESE) | |||
Regulation Medical Specialty | Cardiovascular | |||
510k Review Panel | Cardiovascular | |||
summary | summary | |||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product | No |