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510(k) K822351

POWDER BLOWERS by Kelleher Corp. — Product Code KMA

K822351 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "POWDER BLOWERS". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code KMA (Irrigator, Powered Nasal), a Class I device regulated under 21 CFR 874.5550. 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 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Powered Nasal
Device Class
Class I
Regulation Number
874.5550
Review Panel
EN
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 KMA

  • K140542 — NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (June 27, 2014)
  • K973875 — RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (January 26, 1998)
  • K963550 — RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (November 1, 1996)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)

FDA data resources