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FDA 510(k) Application Details - K024160
Device Classification Name
Elastomer, Silicone, For Scar Management
More FDA Info for this Device
510(K) Number
K024160
Device Name
Elastomer, Silicone, For Scar Management
Applicant
WARNER-LAMBERT CO.
201 TABOR RD.
MORRIS PLAINS, NJ 07950 US
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Contact
JOHN R JACOBS
Other 510(k) Applications for this Contact
Regulation Number
878.4025
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Classification Product Code
MDA
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More FDA Info for this Product Code
Date Received
12/17/2002
Decision Date
03/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K024160
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