FDA 510(k) Application Details - K962026

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K962026
Device Name Vinyl Patient Examination Glove
Applicant HONG HUANG TANG INDUSTRIAL CO., LTD.
34 LINNELL CIRCLE
BILLERICA, MA 01821 US
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Contact HUAN CHUNG LI
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 05/23/1996
Decision Date 09/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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