FDA 510(k) Application Details - K024102

Device Classification Name Latex Patient Examination Glove

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510(K) Number K024102
Device Name Latex Patient Examination Glove
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact ERICA SETHI
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/12/2002
Decision Date 12/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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