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510(k) K822169

SURGICAL HEAD SUPPORT by Kelleher Corp. — Product Code HBM

K822169 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "SURGICAL HEAD SUPPORT". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code HBM (Headrest, Neurosurgical), a Class I device regulated under 21 CFR 882.4440. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1982
Date Received
July 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headrest, Neurosurgical
Device Class
Class I
Regulation Number
882.4440
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 HBM

  • K911918 — SWIVEL HORSESHOE HEADREST (July 17, 1991)
  • K911917 — CODMAN PEDIATRIC HORSESHOE HEADREST (July 17, 1991)

FDA data resources