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510(k) K141700

PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM by Genoray Co., Ltd. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2014
Date Received
June 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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