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FDA 510(k)

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

K-Number: K052099 · 2005-11-21

ApplicantPolyganics B.V.,
Decision Date2005-11-21
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ is the device name listed in this FDA 510(k) record. The listed applicant is Polyganics B.V.,. It received FDA 510(k) clearance on 2005-11-21 under 510(k) number K052099. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ?

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ is a medical device that received FDA 510(k) clearance on 2005-11-21. The listed applicant is Polyganics B.V.,. The 510(k) number is K052099.

When did NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ receive FDA 510(k) clearance?

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ received FDA 510(k) clearance on 2005-11-21, under 510(k) number K052099.

Who is the listed applicant for NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ?

The FDA 510(k) record lists Polyganics B.V., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ?

The FDA product code for NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ is LYA.

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Other records listing Polyganics B.V., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112267NEUROLAC(R) NERVE GUIDEK070715NASOPORE EARK062540NASOPORE EAR, MODELS ND04, ND05K050573NEUROLAC NERVE GUIDEK042811VIVOSORB SHEET, MODEL FS01K032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

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Related Devices (Code: LYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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