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510(k) K041713

SUPER REVO HERCULINE SUTURE ANCHOR by Linvatec Corp. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
June 23, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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