FDA 510(k) Application Details - K970364

Device Classification Name Bed, Flotation Therapy, Powered

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510(K) Number K970364
Device Name Bed, Flotation Therapy, Powered
Applicant APEX METAL, INC.
P.O. BOX 1026
MT. PLEASANT, SC 29465-1026 US
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Contact JEAN ROZINT
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Regulation Number 890.5170

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Classification Product Code IOQ
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Date Received 01/31/1997
Decision Date 11/17/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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