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FDA 510(k)

UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET

K-Number: K053283 · 2006-01-12

ApplicantPajunk GmbH
Decision Date2006-01-12
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2006-01-12 under 510(k) number K053283. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET?

UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET is a medical device that received FDA 510(k) clearance on 2006-01-12. The listed applicant is Pajunk GmbH. The 510(k) number is K053283.

When did UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET receive FDA 510(k) clearance?

UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET received FDA 510(k) clearance on 2006-01-12, under 510(k) number K053283.

Who is the listed applicant for UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET?

The FDA 510(k) record lists Pajunk GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET?

The FDA product code for UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET is CAZ.

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Other records listing Pajunk GmbH 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.

K113207SONO TAP, TUOHY SONOK113209CHIBA SONOK060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVK053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPK043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSK042979MODIFICATION TO: PLEXALONG SETS

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Related Devices (Code: CAZ)

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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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