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510(k) K183296

REAL Immersive System by Penumbra, Inc. — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2019
Date Received
November 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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