NASOPORE-FD— 510(k) K141423

Substantially Equivalent

Polyganics B.V.,

FDA 510(k) clearance K141423 for NASOPORE-FD, Substantially Equivalent on 2014-08-07. Applicant: Polyganics B.V.,. Device class: 1.

Clearance details

Applicant: Polyganics B.V.,
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2014-05-30
Decision date: 2014-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Groningen, NL

Download summary PDF View on FDA.gov ↗

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More clearances from Polyganics B.V.,

K141816 — HEMOPORE2014-10-23
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K070715 — NASOPORE EAR2007-05-07
K062540 — NASOPORE EAR, MODELS ND04, ND052006-10-18
K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ2005-11-21

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