codes
Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass |
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---|---|---|---|---|
510(k) Number | K002118 | |||
Device Name | STOCKERT COMPACT SYSTEM VERSION 2.0 | |||
Original Applicant |
|
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Original Contact | cynthia j. m. nolte | |||
Regulation Number | 870.4220 | |||
Classification Product Code |
|
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Date Received | 07/13/2000 | |||
Decision Date | 08/09/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |