FDA 510(k) Application Details - K972169

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K972169
Device Name Polymer Patient Examination Glove
Applicant PWA INDUSTRIES SDN. BHD.
LOT 93, SEMAMBU INDUST. ESTATE
KUANTAN, PAHANG 25350 MY
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Contact AZMAN ISMAIL
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 06/09/1997
Decision Date 10/03/1997
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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