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FDA 510(k) Application Details - K992938
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
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510(K) Number
K992938
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
LI MEDICAL TECHNOLOGIES, INC.
4 ARMSTRONG RD.
SHELTON, CT 06484 US
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RHODEMANN LI
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Regulation Number
888.3030
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Classification Product Code
MAI
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Date Received
08/31/1999
Decision Date
09/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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