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510(k) K131177

SINUFLUSH LAVAGE SYSTEM by Hedgepath, LLC — Product Code KAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2013
Date Received
April 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances for product code KAR

  • K931398 — GM SWIVEL VIDEO (TM) IRRIGATOR (August 30, 1993)
  • K861298 — FISCH DRILL IRRIGATOR (April 23, 1986)