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510(k) K941823

LEKSELL NEURO GENERATOR AND ACCESSORIES by Elekta Instruments, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
April 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Elekta Instruments, Inc.

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  • K955064 — SPETZLER TI 100 ANEURYSM CLIP (October 17, 1996)
  • K946165 — CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (May 23, 1995)
  • K943468 — LEKSELL SURGIPLAN (January 20, 1995)
  • K932261 — ES-100 ACCESSORIES (January 7, 1994)
  • K925360 — ES-100 POWER SYSTEM, ES-100 SERIES (September 7, 1993)
  • K914808 — LEKSELL GAMMAPLAN (LGP) (January 23, 1992)

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