FDA 510(k) Application Details - K893273

Device Classification Name Latex Patient Examination Glove

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510(K) Number K893273
Device Name Latex Patient Examination Glove
Applicant TIEN YEE SCREEN WORKS CO., LTD.
NO. 7, SEC. 1, YAN HAI ROAD
FU HSING HSIANG, CHANGHUA
HSIEN, TAIWAN, R.O.C. TW
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Contact S. H NIEN
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 04/17/1989
Decision Date 01/17/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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