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510(k) K092898

CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES by Conmed Linvatec — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2009
Date Received
September 21, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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