FDA 510(k) Application Details - K963677

Device Classification Name Mattress, Air Flotation, Alternating Pressure

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510(K) Number K963677
Device Name Mattress, Air Flotation, Alternating Pressure
Applicant 9TH WAVE, INC.
PO BOX 1026
MT. PLEASANT, SC 29465-1026 US
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Contact JEAN ROZINT
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Regulation Number 880.5550

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Classification Product Code FNM
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Date Received 09/13/1996
Decision Date 11/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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