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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia
510(k) Number K172956
Device Name Medicant Mucosal Atomizer
Applicant
Medica Holdings, LLC
5200 Meadows Rd. Suite 150
Lake Oswego,  OR  97035
Applicant Contact George Reed
Correspondent
Medica Holdings, LLC
5200 Meadows Rd. Suite 150
Lake Oswego,  OR  97035
Correspondent Contact Paul Dryden
Regulation Number868.5170
Classification Product Code
CCT  
Date Received09/26/2017
Decision Date 04/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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