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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 K162041
Device Name Airworks Nebulizer pe1200m
Applicant
Convexity Scientific LLC
36 Church Lane
Westport,  CT  06880
Applicant Contact Paul Reiferson
Correspondent
mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Susan D. Goldstein-Falk
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/25/2016
Decision Date 05/02/2017
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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