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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 K972908
Device Name SANDS SERIES III HYPERBARIC CHAMBER
Applicant
Sands Hyperbarics
709 E. Washington Blvd.
Los Angeles,  CA  90021
Applicant Contact LACHLAN SANDS
Correspondent
Sands Hyperbarics
709 E. Washington Blvd.
Los Angeles,  CA  90021
Correspondent Contact LACHLAN SANDS
Regulation Number868.5470
Classification Product Code
CBF  
Date Received08/06/1997
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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