FDA 510(k) Application Details - K961634

Device Classification Name Latex Patient Examination Glove

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510(K) Number K961634
Device Name Latex Patient Examination Glove
Applicant HL RUBBER PRODUCTS SDN BHD
7TH FLOOR, BALAI FELDA
JALAN GURNEY 1
KUALA LUMPUR 54000 MY
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Contact YUNUS LATIF
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 04/29/1996
Decision Date 06/16/1997
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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