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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K970363
Device Name HYDROTEC LOW AIR LOSS THERAPY BED
Applicant
Apex Metal, Inc.
3039 Roswell St.
Los Angeles,  CA  90065
Correspondent
Apex Metal, Inc.
3039 Roswell St.
Los Angeles,  CA  90065
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received01/31/1997
Decision Date 11/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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