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FDA 510(k) Application Details - K042054
Device Classification Name
Elastomer, Silicone Block
More FDA Info for this Device
510(K) Number
K042054
Device Name
Elastomer, Silicone Block
Applicant
SILIMED, INC.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
874.3620
More FDA Info for this Regulation Number
Classification Product Code
MIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2004
Decision Date
02/23/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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