FDA 510(k) Application Details - K970795

Device Classification Name Surgeon'S Gloves

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510(K) Number K970795
Device Name Surgeon'S Gloves
Applicant SHANG HO INDUSTRIAL CORP. LTD.
4-5 NAN PEI 1ST. RD.
CHIANG LI TACHIA
TAICHUNG HSIEN TW
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Contact CHENG KO LIN
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 03/04/1997
Decision Date 12/18/1997
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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