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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K162811
Device Name MR Conditional CGA 870
Applicant
Essex Industries, Inc.
7700 Gravois
St. Louis,  MO  63123
Applicant Contact Russ Jacobsmeyer
Correspondent
Essex Industries, Inc.
7700 Gravois
St. Louis,  MO  63123
Correspondent Contact Paul Dryden
Regulation Number868.2700
Classification Product Code
CAN  
Date Received10/06/2016
Decision Date 03/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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