FDA 510(k) Application Details - K960803

Device Classification Name Drape, Surgical

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510(K) Number K960803
Device Name Drape, Surgical
Applicant RX TEXTILES, INC.
3107 CHAMBER DR.
MONROE, NC 28110 US
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Contact JOSEPH A DAVANT III
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 02/27/1996
Decision Date 07/12/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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