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FDA 510(k) Application Details - K014239
Device Classification Name
Cover, Barrier, Protective
More FDA Info for this Device
510(K) Number
K014239
Device Name
Cover, Barrier, Protective
Applicant
INTERNATIONAL MEDSURG CONNECTION
P.O. BOX 848
GRAYSLAKE, IL 60030 US
Other 510(k) Applications for this Company
Contact
MICHELE H VOVOLKA
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
MMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2001
Decision Date
02/19/2002
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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