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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 K183654
Device Name PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
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 Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received12/27/2018
Decision Date 05/23/2019
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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