FDA 510(k) Application Details - K893275

Device Classification Name Latex Patient Examination Glove

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510(K) Number K893275
Device Name Latex Patient Examination Glove
Applicant PT IKA MUDA CORPORA
LANDMARK CTR.,8TH FL.,JALAN
JEN.SUDIR.70A
JAKARTA 12930 ID
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Contact BONDAN WINARNO
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 04/17/1989
Decision Date 09/15/1989
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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