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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 K183516
Device Name PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
Namsa, Inc.
400 Highway 169 , Suite 500
Minneapolis,  MN  55426
Correspondent Contact Beryl St. Jeanne
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/18/2018
Decision Date 09/06/2019
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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