FDA 510(k) Application Details - K992337

Device Classification Name Patient Examination Glove

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510(K) Number K992337
Device Name Patient Examination Glove
Applicant MEXPO INTL., INC.
2671 MCCONE AVE.
HAYWARD,, CA 94545 US
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Contact TIM THAI
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Regulation Number 880.6250

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Classification Product Code FMC
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Date Received 07/13/1999
Decision Date 08/17/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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