FDA 510(k) Application Details - K090464

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K090464
Device Name Polymer Patient Examination Glove
Applicant PT MAHAKARYA INTI BUANA
JL.SEI BELUMAI DESA DALU 10A
DUSUN I
TANJUNG MORAWA, SUMUT 20362 ID
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Contact AZMAN ISMAIL
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 02/23/2009
Decision Date 04/23/2009
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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