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FDA 510(k) Application Details - K002691
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K002691
Device Name
Drape, Surgical
Applicant
COM-MED INTERNATIONAL, INC.
P.O. BOX 848
GRAYSLAKE, IL 60030 US
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Contact
MICHELE VOVOLKA
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
08/29/2000
Decision Date
12/08/2000
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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