SINUFLUSH LAVAGE SYSTEM— 510(k) K131177

Substantially Equivalent

Hedgepath, LLC

FDA 510(k) clearance K131177 for SINUFLUSH LAVAGE SYSTEM, Substantially Equivalent on 2013-09-20. Applicant: Hedgepath, LLC.

Clearance details

Applicant: Hedgepath, LLC
Product code: Code KAR
Advisory panel: Ear, Nose, Throat
Date received: 2013-04-25
Decision date: 2013-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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