FDA 510(k) Application Details - K070760

Device Classification Name Latex Patient Examination Glove

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510(K) Number K070760
Device Name Latex Patient Examination Glove
Applicant DERMA CARE PLUS PRODUCTS LLC
1500 RIVER PINES DRIVE
GREEN BAY, WI 54311 US
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Contact JOSEPH NEUSER
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 03/20/2007
Decision Date 06/07/2007
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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