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510(k) K936071

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE by Smith & Nephew Dyonics, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
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)
  • K954989 — DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (November 27, 1995)
  • K953695 — DYONICS DISPOSABLE ARTHROSCOPIC BLADES (September 15, 1995)
  • K953387 — ECTRA LIGAMENT RELEASE SYSTEM (August 9, 1995)
  • K945182 — DYONICS FIXATION SCREWS (January 24, 1995)
  • 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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