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510(k) K950078

MICROFLOW IRRIGATION SYSTEM by Jedmed Instrument Co. — Product Code KMA

K950078 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "MICROFLOW IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code KMA (Irrigator, Powered Nasal), a Class I device regulated under 21 CFR 874.5550. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
January 10, 1995
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 Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)
  • K944031 — VIDEO SCOPE SYSTEM (OTOSCOPE) (September 23, 1994)

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)
  • K822351 — POWDER BLOWERS (September 14, 1982)

FDA data resources