FDA 510(k) Application Details - K022530

Device Classification Name Latex Patient Examination Glove

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510(K) Number K022530
Device Name Latex Patient Examination Glove
Applicant HYCARE INTL. CO., LTD.
198 AVE. DE LA D'EMERALD
SPARKS, NV 89434-9550 US
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Contact JANNA P TUCKER
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 07/31/2002
Decision Date 08/26/2002
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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