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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 K210126
Device Name Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
Applicant
The Ritedose Corporation
1 Technology Circle
Columbia,  SC  29203
Applicant Contact Linda Valentine
Correspondent
The Ritedose Corporation
1 Technology Circle
Columbia,  SC  29203
Correspondent Contact Linda Valentine
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/19/2021
Decision Date 12/03/2021
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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