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510(k) K011273

SI ASCOPE by Astron Clinica Limited — Product Code PSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2002
Date Received
April 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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