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510(k) K822204

ENT MALLETS by Kelleher Corp. — Product Code GFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
July 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mallet, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Kelleher Corp.

  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (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)

Other clearances for product code GFJ

  • K851789 — 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY (June 20, 1985)
  • K844017 — MICROTENS 7757 T.E.N.S. STIMULATOR (November 30, 1984)