FDA 510(k) Application Details - K893266

Device Classification Name Latex Patient Examination Glove

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510(K) Number K893266
Device Name Latex Patient Examination Glove
Applicant YI-GANG MACHINERY & ENGINEERING CO., LTD.
6F-5 CRYSTAL BLDE NO. HSIN YI
RD SEC. 4
TAIPEI 10056 TW
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Contact SHENG-TA KAO
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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 06/14/1989
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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