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510(k) K954989

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES by Smith & Nephew Dyonics, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1995
Date Received
October 31, 1995
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 Smith & Nephew Dyonics, Inc.

  • K955914 — LIMITED REUSE ARTHROSCOPIC BLADES (February 8, 1996)
  • K954627 — ECTRA II LIGAMENT RELEASE SYSTEM (December 18, 1995)
  • K953695 — DYONICS DISPOSABLE ARTHROSCOPIC BLADES (September 15, 1995)
  • K953387 — ECTRA LIGAMENT RELEASE SYSTEM (August 9, 1995)
  • K945182 — DYONICS FIXATION SCREWS (January 24, 1995)
  • K936071 — SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE (August 19, 1994)
  • K934299 — DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION (February 14, 1994)
  • K920267 — DYONICS ARTHROSCOPIC KIT (March 23, 1993)
  • K922176 — INTELIJET SUCTION SUPPLY (November 18, 1992)
  • K914963 — SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET (June 4, 1992)

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