FDA 510(k) Application Details - K955586

Device Classification Name Gown, Surgical

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510(K) Number K955586
Device Name Gown, Surgical
Applicant ROBISON & SMITH, INC.
335 NORTH MAIN ST.
GLOVERSVILLE, NY 12078 US
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Contact RICHARD SMITH
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Regulation Number 878.4040

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Classification Product Code FYA
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Date Received 12/07/1995
Decision Date 08/30/1996
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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