FDA 510(k) Application Details - K060200

Device Classification Name Drape, Surgical

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510(K) Number K060200
Device Name Drape, 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 878.4370

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Classification Product Code KKX
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Date Received 01/26/2006
Decision Date 05/31/2006
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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