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510(k) K163247

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider by Laurimed, LLC — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2017
Date Received
November 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

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  • K082194 — LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (August 28, 2008)
  • K080140 — LAURIMED SPINAL INJECTION SYSTEM (May 9, 2008)

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