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FDA 510(k) Application Details - K002488
Device Classification Name
Elastomer, Silicone, For Scar Management
More FDA Info for this Device
510(K) Number
K002488
Device Name
Elastomer, Silicone, For Scar Management
Applicant
ADVANCED BIO-TECHNOLOGIES, INC.
53 NEEDHAM DR.
SUITE 5, CW4 8FB
CRANAGE, CHESHIRE CW4 8FB GB
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Contact
DAVID BRYANT
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
08/14/2000
Decision Date
01/05/2001
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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