FDA 510(k) Application Details - K960842

Device Classification Name Latex Patient Examination Glove

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510(K) Number K960842
Device Name Latex Patient Examination Glove
Applicant CROCKER INDUSTRIAL RESOURCES SDN. BHD.
12011 GUILFORD RD.
SUITE 101
ANNAPOLIS JUNTION, MD US
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Contact TIMOTHY F HAND
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 02/27/1996
Decision Date 03/19/1997
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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