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510(k) K013620

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION by Medstone Intl., Inc. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2002
Date Received
November 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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