FDA 510(k) Application Details - K994098

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K994098
Device Name Vinyl Patient Examination Glove
Applicant EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD.
THE NORTH OF BEISHIMEN VILLAGE
#1,EVERGREEN RD., XIAZUO TOWN
SHIJIAZHUANG CITY,HEBEI PROV. 050306 CN
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Contact DOREEN FENG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 12/03/1999
Decision Date 05/23/2000
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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