FDA 510(k) Application Details - K982897

Device Classification Name Latex Patient Examination Glove

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510(K) Number K982897
Device Name Latex Patient Examination Glove
Applicant P.T. MAJA AGUNG LATEXINDO
345 CLOVERLEAF DRIVE, SUITE B
BALDWIN PARK, CA 91706 US
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Contact EMMY TJOENG
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 08/17/1998
Decision Date 12/23/1998
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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