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FDA 510(k), K093857, C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
FDA 510(k), K093857, C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
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510(K) Number: K093857
Device Name: C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
Manufacturer: CHRISTINE BRAUER
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: KXA
Date Received: 12/16/2009
Decision Date: 04/30/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
Manufacturer: CHRISTINE BRAUER
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: KXA
Date Received: 12/16/2009
Decision Date: 04/30/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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