FDA 510(k) Application Details - K001862

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K001862
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
12390 EAST END AVE.
CHINO, CA 91710 US
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Contact JAMES CHU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 06/19/2000
Decision Date 06/30/2000
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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