FDA 510(k) Application Details - K002112

Device Classification Name Latex Patient Examination Glove

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510(K) Number K002112
Device Name Latex Patient Examination Glove
Applicant PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
EMPAT, SENAWANG INDUSTRIAL
ESTATE, 70450 SEREMBAN, NEGERI
SEMBILAN DARUL KHUSUS MALAYSIA ML
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Contact PETER YEW NEING CHOON
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 07/12/2000
Decision Date 08/14/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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