DeviceClearance

NASOPORE EAR— 510(k) K070715

Substantially Equivalent

Polyganics B.V.,

FDA 510(k) clearance K070715 for NASOPORE EAR, Substantially Equivalent on 2007-05-07. Applicant: Polyganics B.V.,. Device class: 2.

Clearance details

Applicant
Polyganics B.V.,
Product code
Code NHB
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Groningen, NL
Download summary PDFView on FDA.gov ↗

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Recalls naming K070715

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070715.

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