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FDA 510(k), K101887, CONFIDENT SURGERY SUITE 300, MODEL CSS300
FDA 510(k), K101887, CONFIDENT SURGERY SUITE 300, MODEL CSS300
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510(K) Number: K101887
Device Name: CONFIDENT SURGERY SUITE 300, MODEL CSS300
Manufacturer: SURGICEYE GMBH
Device Classification Name: probe, uptake, nuclear
Regulation Number: 892.1320
Classification Product Code: IZD
Date Received: 07/06/2010
Decision Date: 03/22/2011
Regulation Medical Specialty: Radiology
Device Name: CONFIDENT SURGERY SUITE 300, MODEL CSS300
Manufacturer: SURGICEYE GMBH
Device Classification Name: probe, uptake, nuclear
Regulation Number: 892.1320
Classification Product Code: IZD
Date Received: 07/06/2010
Decision Date: 03/22/2011
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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