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FDA 510(k) Application Details - K023432
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K023432
Device Name
Drape, Surgical
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
ANDREA HAFERKAMP
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
10/15/2002
Decision Date
11/04/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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