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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K173554
Device Name PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645 -1782
Applicant Contact James W. Monroe
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645 -1782
Correspondent Contact James W. Monroe
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Codes
EOB   ITX  
Date Received11/17/2017
Decision Date 01/19/2018
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
Predetermined Change
Control Plan Authorized		 No
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