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510(k) K932261

ES-100 ACCESSORIES by Elekta Instruments, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
April 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Elekta Instruments, Inc.

  • K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (January 15, 1999)
  • K955064 — SPETZLER TI 100 ANEURYSM CLIP (October 17, 1996)
  • K941823 — LEKSELL NEURO GENERATOR AND ACCESSORIES (March 22, 1996)
  • K946165 — CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (May 23, 1995)
  • K943468 — LEKSELL SURGIPLAN (January 20, 1995)
  • K925360 — ES-100 POWER SYSTEM, ES-100 SERIES (September 7, 1993)
  • K914808 — LEKSELL GAMMAPLAN (LGP) (January 23, 1992)

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  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)