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510(k) K161774

i-Sil by Spident Co., Ltd. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2016
Date Received
June 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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