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510(k) K140542

NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER by Rhinosystems, Inc. — Product Code KMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2014
Date Received
March 4, 2014
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 for product code KMA

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