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510(k) K130497

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION by Linvatec Corporation D/B/A Conmed Linvatec — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2013
Date Received
February 26, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

Other clearances by Linvatec Corporation D/B/A Conmed Linvatec

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  • K121890 — GENESYS PRESSFT SUTURE ANCHOR (August 22, 2012)
  • K112965 — NANO SUTURE ANCHOR (November 2, 2011)

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