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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K183586
Device Name CapMedic
Applicant
Cognita Labs, LLC
700 N Main St. Suite C1
Santa Ana,  CA  92701
Applicant Contact Rajoshi Biswas
Correspondent
Cognita Labs, LLC
700 N Main St. Suite C1
Santa Ana,  CA  92701
Correspondent Contact Rajoshi Biswas
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Code
BZK  
Date Received12/21/2018
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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