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510(k) K822016

NAGASHIMA SN-SP UNIT AND CHAIR by Kelleher Corp. — Product Code ETF

K822016 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "NAGASHIMA SN-SP UNIT AND CHAIR". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. 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
July 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
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)

Other clearances for product code ETF

  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910781 — #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (May 15, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)

FDA data resources