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FDA 510(k) Application Details - K981387
Device Classification Name
Elastomer, Silicone, For Scar Management
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510(K) Number
K981387
Device Name
Elastomer, Silicone, For Scar Management
Applicant
MEDICAL SCIENTIFIC, INC.
125 JOHN HANCOCK RD.
TAUNTON, MA 02780 US
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Contact
PAUL NARDELLA
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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
04/16/1998
Decision Date
06/10/1998
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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