FDA 510(k) Application Details - K954293

Device Classification Name Latex Patient Examination Glove

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510(K) Number K954293
Device Name Latex Patient Examination Glove
Applicant MEDLINE PRODUCTS CO. LTD.
85 MOO 4, ASIA-CHANA HWY.
NAMOM SUB-DISTRICT
SONGKHLA 90310 TH
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Contact RAJEEV KUMAR SOOD
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 09/14/1995
Decision Date 07/26/1996
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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