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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 K223144
Device Name Galaxy System
Applicant
Noah Medical Corp.
1501 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact Sam Mostafavi
Correspondent
Noah Medical Corp.
1501 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact Sam Mostafavi
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/04/2022
Decision Date 03/01/2023
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
Recalls CDRH Recalls
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