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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 K081506
Device Name HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
Applicant
Hyperbaric America, LLC
1811 Copper Ridge Dr.
San Antonio,  TX  78259
Applicant Contact TOM WORKMAN
Correspondent
Hyperbaric America, LLC
1811 Copper Ridge Dr.
San Antonio,  TX  78259
Correspondent Contact TOM WORKMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/29/2008
Decision Date 07/25/2008
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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