FDA 510(k) Application Details - K052169

Device Classification Name Drape, Surgical

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510(K) Number K052169
Device Name Drape, Surgical
Applicant INTERNATIONAL MEDSURG CONNECTION, INC.
935 NORTH PLUM GROVE RD.
SUITE F
SCHAUMBURG, IL 60173 US
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Contact MANNY GUPTA
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 08/09/2005
Decision Date 11/17/2005
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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