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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 , No.22, Sec. 2, Sheng Yi Road., Hsinchu Science Park
Zhubei City
Hsinchu County,  TW 30261
Applicant Contact TSUNG-MIN HSIEH
Correspondent
Somnics Inc.
5F , No.22, Sec. 2, Sheng Yi Road., 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
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