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FDA 510(k), K130453, EXCELSIOR
FDA 510(k), K130453, EXCELSIOR
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510(K) Number: K130453
Device Name: EXCELSIOR
Manufacturer: EYEKOR, LLC.
Device Classification Name: system, image management, ophthalmic
Regulation Number: 892.2050
Classification Product Code: NFJ
Date Received: 02/22/2013
Decision Date: 04/02/2013
Regulation Medical Specialty: Radiology
Device Name: EXCELSIOR
Manufacturer: EYEKOR, LLC.
Device Classification Name: system, image management, ophthalmic
Regulation Number: 892.2050
Classification Product Code: NFJ
Date Received: 02/22/2013
Decision Date: 04/02/2013
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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