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510(k) K153583

BioVision Plus by Faxitron Bioptics, LLC — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2016
Date Received
December 15, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K122428 — FAXITRON SPECIEN RADIOGRAPHY SYSTEM (September 25, 2012)

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