FDA 510(k) Application Details - K022765

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K022765
Device Name Polymer Patient Examination Glove
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW 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 LZA
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Date Received 08/20/2002
Decision Date 10/11/2002
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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