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510(k) K202391

DIR 800 by Aesculap, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2021
Date Received
August 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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