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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K152660
Device Name HYPNOSPAD
Applicant
Somnics, Inc.
5f, # 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
Zhubei City
Hsinchu County,  TW 30261
Applicant Contact TSUNG-MIN HSIEH
Correspondent
Somnics, Inc.
5f, # 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,
Zhubei City
Hsinchu County,  TW 30261
Correspondent Contact TSUNG-MIN HSIEH
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/17/2015
Decision Date 11/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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