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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 K203155
Device Name BreatheSuite MDI V1
Applicant
BreatheSuite Inc
29 Rowan Street
Unit 2
St. John's,  CA A1B2X2
Applicant Contact Brett Vokey
Correspondent
BreatheSuite Inc
29 Rowan Street
Unit 2
St. John's,  CA A1B2X2
Correspondent Contact Brett Vokey
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/22/2020
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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