FDA 510(k) Application Details - K992289

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K992289
Device Name Vinyl Patient Examination Glove
Applicant VITALCARE GROUP, INC.
15800 N.W. 13TH AVE.
MIAMI, FL 33169 US
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Contact GINGER TALLEY
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 07/07/1999
Decision Date 08/04/1999
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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