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FDA 510(k) Application Details - K020581
Device Classification Name
Drape, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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
FDA Source Information for K020581
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