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510(k) K002464

SMITH & NEPHEW OFF-CENTERED PORP by Gyrus Ent LLC — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2000
Date Received
August 10, 2000
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)

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