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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ent manual surgical
510(k) Number K121351
Device Name SINUS DILATION SYSTEM
Applicant
ENTRIGUE SURGICAL, INC.
12672 SILICON DR. STE 150
SAN ANTONIO,  TX  78249
Applicant Contact GABRIELE G NIEDERAUER, PH.D.
Correspondent
ENTRIGUE SURGICAL, INC.
12672 SILICON DR. STE 150
SAN ANTONIO,  TX  78249
Correspondent Contact GABRIELE G NIEDERAUER, PH.D.
Regulation Number874.4420
Classification Product Code
LRC  
Date Received05/04/2012
Decision Date 08/29/2012
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
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