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FDA 510(k), K161509, 3D OCT-1 Maestro
FDA 510(k), K161509, 3D OCT-1 Maestro
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510(K) Number: K161509
Device Name: 3D OCT-1 Maestro
Manufacturer: Charles Reisman
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: KXA
Date Received: 06/01/2016
Decision Date: 07/28/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: 3D OCT-1 Maestro
Manufacturer: Charles Reisman
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: KXA
Date Received: 06/01/2016
Decision Date: 07/28/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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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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