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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K163277
Device Name SuperNO2VA Device
Applicant
Revolutionary Medical Devices, Inc.
4090 E Bujia Primera
Tucson,  AZ  85718
Applicant Contact David M. Kane
Correspondent
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received11/21/2016
Decision Date 10/13/2017
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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