FDA 510(k), K102599, TOMOPHASE OCTIS

FDA 510(k), K102599, TOMOPHASE OCTIS

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510(K) Number: K102599
Device Name: TOMOPHASE OCTIS
Manufacturer: TOMOPHASE CORPORATION
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 09/10/2010
Decision Date: 12/01/2010
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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