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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Nasal
510(k) Number K120665
Device Name INVENT SNORING DEVICE
Applicant
Ventus Medical, Inc.
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Applicant Contact CINDY DOMECUS
Correspondent
Ventus Medical, Inc.
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact CINDY DOMECUS
Regulation Number874.3900
Classification Product Code
LWF  
Date Received03/05/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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