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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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