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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 K040145
Device Name ATA HCM MONOPLACE HYPERBARIC SYSTEM
Applicant
ATA HYPERBARIC CHAMBER MANUFACTURING
695-ALPHA STREET
VICTORIA, BC,  CA
Applicant Contact HUMPHREY KILLAM
Correspondent
ATA HYPERBARIC CHAMBER MANUFACTURING
695-ALPHA STREET
VICTORIA, BC,  CA
Correspondent Contact HUMPHREY KILLAM
Regulation Number868.5470
Classification Product Code
CBF  
Date Received01/22/2004
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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