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510(k) K150468

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs by K2 Medical GmbH & Co. KG — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2016
Date Received
February 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

Other clearances by K2 Medical GmbH & Co. KG

  • K120492 — K2 MEDICAL VASCULAR CLAMPS (April 30, 2012)

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