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510(k) K822012

BINOCULAR OPERATING MICROSCOPES & by Kelleher Corp. — Product Code HBN

K822012 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "BINOCULAR OPERATING MICROSCOPES &". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code HBN (Chair, Neurosurgical), a Class I device regulated under 21 CFR 882.4125. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
July 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Neurosurgical
Device Class
Class I
Regulation Number
882.4125
Review Panel
NE
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 HBN

  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)
  • K822428 — SURGI-QUIP MICROSCOPE STAND (September 2, 1982)
  • K822426 — MCINTYRE MICROSCOPE STAND (September 2, 1982)

FDA data resources