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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: KXA
Date Received: 10/27/2004
Decision Date: 01/19/2005
Decision: 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: KXA
Date Received: 10/27/2004
Decision Date: 01/19/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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