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510(k) K171851

SOFTXIL by Bistool — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
June 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone Block
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

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