FDA 510(k) Application Details - K982114

Device Classification Name Latex Patient Examination Glove

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510(K) Number K982114
Device Name Latex Patient Examination Glove
Applicant M/S MIDLAND LATEX PRODUCTS LTD.
915 BLUE GENTIAN RD.
SUITE #1
EAGAN, MN 55121 US
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Contact ANIL SEGAT
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 06/16/1998
Decision Date 01/21/1999
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



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