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510(k) K173362

DSM Biomedical Calcium Phosphate Cement by Kensey Nash Corporation Dba Dsm Biomedical — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2018
Date Received
October 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Kensey Nash Corporation Dba Dsm Biomedical

  • K173572 — DSM Biomedical Calcium Phosphate Cement with Microspheres (May 9, 2018)
  • K170245 — DSM Biomedical Dental Bone Graft (May 16, 2017)
  • K160474 — DSM Biomedical Porcine Pericardium Dental Membrane (June 7, 2016)
  • K141738 — MEDEOR MATRIX WOUND DRESSING (February 17, 2015)
  • K133169 — MESO TENDON MATRIX (December 20, 2013)
  • K132025 — MESO BILAYER SURGICAL MESH (October 30, 2013)

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