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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 K172156
Device Name PENTAX Medical EPK-3000 Video Imaging System
Pentax Medical
3 Paragon Drive
Montvale,  NJ  07645
Applicant Contact William Goeller
Pentax Medical
3 Paragon Drive
Montvale,  NJ  07645
Correspondent Contact James W. Monroe
Regulation Number874.4760
Classification Product Code
Subsequent Product Code
Date Received07/18/2017
Decision Date 04/05/2018
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