FDA 510(k) Application Details - K893296

Device Classification Name Latex Patient Examination Glove

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510(K) Number K893296
Device Name Latex Patient Examination Glove
Applicant MIDAS INTL. DEVELOPMENT CORP.
103 E. RODRIGUEZ AVE., BO.
UGONG, PASIG METRO MANILA
PHILIPPINES RP
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Contact DANILO O IBAY
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 04/18/1989
Decision Date 07/24/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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