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FDA 510(k), K042961, SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
FDA 510(k), K042961, SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
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510(K) Number: K042961
Device Name: SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
Manufacturer: ALLISON MANNERS
Device Classification Name: System, X-Ray, Angiographic
Regulation Number: IZI
Classification Product Code: 10/27/2004
Date Received: 01/19/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
Manufacturer: ALLISON MANNERS
Device Classification Name: System, X-Ray, Angiographic
Regulation Number: IZI
Classification Product Code: 10/27/2004
Date Received: 01/19/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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