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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 K081542
Device Name MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
Applicant
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH,  MN  55446
Applicant Contact Sew-Wah Tay
Correspondent
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH,  MN  55446
Correspondent Contact Sew-Wah Tay
Regulation Number874.4420
Classification Product Code
LRC  
Date Received06/02/2008
Decision Date 06/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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