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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 K180871
Device Name Portable Nebulizer
Applicant
MicroBase Technology Corporation
No. 756, Jiadong Road
Bade District, Taoyuan City,  TW 33464
Applicant Contact Molly Hsieh
Correspondent
MicroBase Technology Corporation c/o ProMedic, LLC.
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/03/2018
Decision Date 09/14/2018
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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