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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 K142541
Device Name POCKET NEB
Applicant
MicroVaper Devices
2682 West Fairbanks Ave.
Winter Park,  FL  32789
Applicant Contact Scott Faris
Correspondent
MicroVapor Devices
2682 West Fairbanks Ave.
Winter Park,  FL  32789
Correspondent Contact Terrence O'Brien
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/10/2014
Decision Date 01/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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