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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 K031649
Device Name SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
Applicant
FINK ENGINEERING PTY LTD
18111 COPPER RIDGE DRIVE
SAN ANTONIO,  TX  78259
Applicant Contact W.T. WORKMAN
Correspondent
FINK ENGINEERING PTY LTD
18111 COPPER RIDGE DRIVE
SAN ANTONIO,  TX  78259
Correspondent Contact W.T. WORKMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received05/28/2003
Decision Date 12/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
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