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FDA 510(k), K071079, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
FDA 510(k), K071079, SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
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510(K) Number: K071079
Device Name: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
Manufacturer: GAMBRO BCT, INC.
Device Classification Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 04/17/2007
Decision Date: 08/02/2007
Regulation Medical Specialty:
Device Name: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
Manufacturer: GAMBRO BCT, INC.
Device Classification Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 04/17/2007
Decision Date: 08/02/2007
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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