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FDA 510(k) Application Details - K023678
Device Classification Name
Elastomer, Silicone, For Scar Management
More FDA Info for this Device
510(K) Number
K023678
Device Name
Elastomer, Silicone, For Scar Management
Applicant
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
5871 LONE PINE PLACE
PASO ROBLES, CA 93446 US
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Contact
CATHERINE RIPLE
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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
11/01/2002
Decision Date
01/23/2003
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
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