FDA 510(k) Application Details - K915126

Device Classification Name Latex Patient Examination Glove

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510(K) Number K915126
Device Name Latex Patient Examination Glove
Applicant HEDD ROZ CANADA, INC.
P.O.BOX 40027
HIGHFIELD P.O.CALGARY
ALBERTA T2G5G5 CA
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Contact TREVOR REIDY
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 11/13/1991
Decision Date 02/11/1992
Decision SE - Substantially Equivalent
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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