ETHMOID SINUS SPACER— 510(k) K062458

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K062458 for ETHMOID SINUS SPACER, Substantially Equivalent on 2006-09-15. Applicant: Acclarent, Inc.. Device class: 1.

Clearance details

Applicant: Acclarent, Inc.
Product code: Code KAM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2006-08-23
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rmenlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.