FDA 510(k) Application Details - K062899

Device Classification Name Gown, Surgical

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510(K) Number K062899
Device Name Gown, Surgical
Applicant MICROTEK MEDICAL, INC.
512 LEHMBERG RD.
COLUMBUS, MS 39702 US
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Contact THOMAS BONNER
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Regulation Number 878.4040

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Classification Product Code FYA
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Date Received 09/27/2006
Decision Date 01/25/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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