FDA 510(k) Application Details - K963211

Device Classification Name Latex Patient Examination Glove

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510(K) Number K963211
Device Name Latex Patient Examination Glove
Applicant AMERICAN HEALTHCARE PRODUCTS, INC.
4923 HASKELL AVE.
ENCINO, CA 91436 US
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Contact TONY DJIE
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 08/16/1996
Decision Date 11/22/1996
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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