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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 K152466
Device Name Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
Applicant
PROSURG, INC
2193 Trade Zone Blvd
San Jose,  CA  95131
Applicant Contact Ashvin Desai
Correspondent
PROSURG, INC
2193 Trade Zone Blvd
San Jose,  CA  95131
Correspondent Contact Ashvin Desai
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/31/2015
Decision Date 05/19/2016
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
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