Home / 510(k) Clearances / K822568

510(k) K822568

EAR PROBES by Kelleher Corp. — Product Code EKL

K822568 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "EAR PROBES". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code EKL (Point, Silver, Endodontic), a Class I device regulated under 21 CFR 872.3840. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Silver, Endodontic
Device Class
Class I
Regulation Number
872.3840
Review Panel
DE
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)
  • 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)

Other clearances for product code EKL

  • K992582 — PACIFIC IMPLANT TITANIUM ENDODONTIC POINT (October 21, 1999)
  • K961089 — PULPDENT ENDOPREP II (April 23, 1996)

FDA data resources