FDA 510(k), K130419, PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k), K130419, PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

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510(K) Number: K130419
Device Name: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer: GENORAY CO., LTD.
Device Classification Name: system, x-ray, extraoral source, digital
Regulation Number: 872.1800
Classification Product Code: MUH
Date Received: 02/19/2013
Decision Date: 11/06/2013
Regulation Medical Specialty: Dental
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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