FDA 510(k) Application Details - K020581

Device Classification Name Drape, Surgical

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510(K) Number K020581
Device Name Drape, Surgical
Applicant MEDICAL CONCEPTS DEVELOPMENT, INC.
2500 VENTURA DR.
WOODBURY, MN 55125-3927 US
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Contact ERIC EUTENEUER
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 02/21/2002
Decision Date 09/18/2002
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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