FDA 510(k) Application Details - K023153

Device Classification Name Latex Patient Examination Glove

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510(K) Number K023153
Device Name Latex Patient Examination Glove
Applicant ANSELL HEALTHCARE PRODUCTS, INC.
1875 HARSH AVENUE, S.E.
MASSILLON, OH 44646-7199 US
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Contact JAMES R CHATTERTON
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 09/23/2002
Decision Date 11/13/2002
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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