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510(k) K033554

SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS by Gyrus Ent LLC — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2003
Date Received
November 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

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  • 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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