FDA 510(k) Application Details - K972291

Device Classification Name Latex Patient Examination Glove

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510(K) Number K972291
Device Name Latex Patient Examination Glove
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact MARYALICE SMITH
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 06/19/1997
Decision Date 07/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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