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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K130068
Device Name DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
Applicant
Essex Industries, Inc. D/B/A Essex Cryogenics of M
8007 Chivvis Dr.
St. Louis,  MO  63123 -2395
Applicant Contact KEN SEISE
Correspondent
Essex Industries, Inc. D/B/A Essex Cryogenics of M
8007 Chivvis Dr.
St. Louis,  MO  63123 -2395
Correspondent Contact KEN SEISE
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received01/11/2013
Decision Date 07/19/2013
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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