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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 K021689
Device Name PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
Applicant
Pan-America Hyperbarics, Inc.
18111 Copper Ridge Dr.
San Antonio,  TX  78259 -3612
Applicant Contact W. T WORKMAN
Correspondent
Pan-America Hyperbarics, Inc.
18111 Copper Ridge Dr.
San Antonio,  TX  78259 -3612
Correspondent Contact W. T WORKMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/23/2002
Decision Date 10/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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