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510(k) K023070

SODEM HIGH SPEED SYSTEM (PNEUMATIC) by Sodemsystems — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2003
Date Received
September 16, 2002
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

Other clearances by Sodemsystems

  • K023066 — DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (November 25, 2002)
  • K012453 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) (October 22, 2001)
  • K012457 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) (October 22, 2001)
  • K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) (September 21, 2001)
  • K993851 — SODEM PERFORATOR DRIVE (December 27, 1999)
  • K994175 — MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE (December 21, 1999)
  • K935567 — SODEM POWER SYSTEM (January 21, 1994)

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