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510(k) K822011

SHEA'S EAR SPECULUM HOLDER PORT MANNS by Kelleher Corp. — Product Code JYK

K822011 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "SHEA'S EAR SPECULUM HOLDER PORT MANNS". The FDA issued a decision of Substantially Equivalent on August 12, 1982. The device falls under product code JYK (Holder, Ear Speculum), a Class I device regulated under 21 CFR 878.1800. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1982
Date Received
July 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Ear Speculum
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type

Other clearances by Kelleher Corp.

  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (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)

FDA data resources