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FDA 510(k), K131103, XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
FDA 510(k), K131103, XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
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510(K) Number: K131103
Device Name: XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: reservoir, blood, cardiopulmonary bypass
Regulation Number: 870.4400
Classification Product Code: DTN
Date Received: 04/19/2013
Decision Date: 06/06/2013
Regulation Medical Specialty: Cardiovascular
Device Name: XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: reservoir, blood, cardiopulmonary bypass
Regulation Number: 870.4400
Classification Product Code: DTN
Date Received: 04/19/2013
Decision Date: 06/06/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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