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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K082569
Device Name ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
Applicant
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH,  MN  55446
Applicant Contact Sew-Wah Tay
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/05/2008
Decision Date 09/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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