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FDA 510(k) Application Details - K991970
Device Classification Name
Elastomer, Silicone, For Scar Management
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510(K) Number
K991970
Device Name
Elastomer, Silicone, For Scar Management
Applicant
PILLAR SURGICAL
PO BOX 8141
LA JOLLA, CA 92038 US
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Contact
ROB FRITZENKOTTER
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
06/11/1999
Decision Date
10/25/1999
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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