FDA 510(k) Application Details - K955670

Device Classification Name Latex Patient Examination Glove

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510(K) Number K955670
Device Name Latex Patient Examination Glove
Applicant CONCORDIA RESEARCH LAB
1812 NORTH VERMONT AVE.
LOS ANGELES, CA 90027 US
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Contact CHARLES H RABBIE
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/08/1995
Decision Date 03/06/1996
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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