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510(k) K102285

KRYSTALRAD (ATAL8) by Medicatech USA — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2011
Date Received
August 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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