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510(k) K152660

HYPNOSPAD by Somnics, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2016
Date Received
September 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Somnics, Inc.

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