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FDA 510(k), K131553, XTRA
FDA 510(k), K131553, XTRA
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510(K) Number: K131553
Device Name: XTRA
Manufacturer: SORIN GROUP DEUTSCHLAND GMBH
Device Classification Name: apparatus, autotransfusion
Regulation Number: 868.5830
Classification Product Code: CAC
Date Received: 05/30/2013
Decision Date: 03/21/2014
Regulation Medical Specialty: Anesthesiology
Device Name: XTRA
Manufacturer: SORIN GROUP DEUTSCHLAND GMBH
Device Classification Name: apparatus, autotransfusion
Regulation Number: 868.5830
Classification Product Code: CAC
Date Received: 05/30/2013
Decision Date: 03/21/2014
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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