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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 K170853
Device Name InnoSpire Go
Applicant
Respironics Respiratory Drug Delivery (Uk) , Ltd.
Chichester Business Park, City Fields Way, Tangmere
Chichester,  GB PO20 2FT
Applicant Contact Filippo Quadrelli
Correspondent
Respironics Respiratory Drug Delivery (Uk) Ltd. C/O Promedic
24301 Woodsage Dr.
Bonita Springs,  FL  36134
Correspondent Contact Paul Dryden
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/22/2017
Decision Date 11/02/2017
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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