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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 K182846
Device Name PENTAX Medical EPK-3000 Video Imaging System
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645 -1782
Correspondent Contact William Goeller
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
PEA  
Date Received10/09/2018
Decision Date 01/09/2019
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
Predetermined Change
Control Plan Authorized		 No
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