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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 K201146
Device Name Ion Endoluminal System
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
sunnyvale,  CA  94086
Applicant Contact jennifer siu
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
sunnyvale,  CA  94086
Correspondent Contact jennifer siu
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/29/2020
Decision Date 06/26/2020
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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