FDA 510(k) Application Details - K963742

Device Classification Name Latex Patient Examination Glove

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510(K) Number K963742
Device Name Latex Patient Examination Glove
Applicant ARISTA MEDI PRIMA
769 MORNINGSIDE DR.
MILLBRAE, CA 94030 US
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Contact CHAIRINA BREDER
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 09/17/1996
Decision Date 11/20/1996
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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