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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Contact 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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