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510(k) K822618

EMERGENCY TRACHEOSTOMY INSTRUMENT SET by Kelleher Corp. — Product Code LJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
September 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tracheotome
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
  • K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
  • K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
  • K822259 — LARYNGEAL SPATULAS (October 22, 1982)
  • K822004 — FACE SHIELDS (October 20, 1982)
  • K822185 — LARYNGEAL SYRINGE (October 18, 1982)

Other clearances for product code LJW

  • K933570 — RESOLUTION(TM) HIP STEM (March 7, 1994)