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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
Model 621-60100
Device Name SINUS DILATION SYSTEM
Original Applicant
ENTRIGUE SURGICAL, INC.
12672 silicon dr. ste 150
san antonio,  TX  78249
Original 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 (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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