FDA 510(k) Application Details - K990746

Device Classification Name Latex Patient Examination Glove

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510(K) Number K990746
Device Name Latex Patient Examination Glove
Applicant SOUTHLAND PRODUCTS CO., LTD.
55 RAJYINDEE RD.
HATYAI, SONGKHLA 90110 TH
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Contact NG PENG LEONG
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 03/08/1999
Decision Date 03/23/1999
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

FDA Source Information for K990746


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