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FDA 510(k) Application Details - K982051
Device Classification Name
Elastomer, Silicone, For Scar Management
More FDA Info for this Device
510(K) Number
K982051
Device Name
Elastomer, Silicone, For Scar Management
Applicant
ALLIED BIOMEDICAL CORP.
3850 RAMADA DR., SUITE C-2
PASO ROBLES, CA 93446 US
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Contact
CATHERINE RIPLE
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
06/11/1998
Decision Date
08/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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