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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K011592
Device Name OXYGEN TREATMENT HOOD
Applicant
AMRON INTERNATIONAL DIVING SUPPLY, INC.
759 WEST FOURTH AVE.
ESCONDIDO,  CA  92025
Applicant Contact NORMA F OCKWIG
Correspondent
AMRON INTERNATIONAL DIVING SUPPLY, INC.
759 WEST FOURTH AVE.
ESCONDIDO,  CA  92025
Correspondent Contact NORMA F OCKWIG
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/24/2001
Decision Date 06/19/2002
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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