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510(k) K034004

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE by Gyrus Ent LLC — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2004
Date Received
December 24, 2003
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 Gyrus Ent LLC

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  • K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (November 24, 2003)
  • K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING IN (May 2, 2003)
  • K021595 — GYRUS ENT NERVE STIMULATOR (October 24, 2002)
  • K021777 — GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND P (August 26, 2002)
  • K020778 — GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 (May 28, 2002)
  • K020067 — GYRUS ENT SOMNOPLASTY GENERATOR (April 4, 2002)
  • K020594 — DIEGO POWERED DISSECTOR AND DRILL SYSTEM (March 8, 2002)
  • K003214 — SMITH & NEPHEW PISTONS (October 31, 2000)

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