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FDA 510(k) Application Details - K990651
Device Classification Name
Elastomer, Silicone, For Scar Management
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510(K) Number
K990651
Device Name
Elastomer, Silicone, For Scar Management
Applicant
UNITED HOSPITAL TECHNOLOGIES, INC.
10320 USA TODAY WAY
MIRAMAR, FL 33025 US
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Contact
SAMUEL SWETLAND
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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
03/01/1999
Decision Date
08/13/1999
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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