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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 K021693
Device Name PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
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 Received05/22/2002
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
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