EPISTAT-II NASAL CATHETER— 510(k) K943718

Substantially Equivalent

Merocel Corp.

FDA 510(k) clearance K943718 for EPISTAT-II NASAL CATHETER, Substantially Equivalent on 1994-09-16. Applicant: Merocel Corp.. Device class: 1.

Clearance details

Applicant: Merocel Corp.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1994-08-01
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mystic, CT, 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.