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FDA 510(k)

MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS

K-Number: K043130 · 2004-12-21

ApplicantPajunk GmbH
Decision Date2004-12-21
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K043130. 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 MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS?

MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Pajunk GmbH. The 510(k) number is K043130.

When did MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS receive FDA 510(k) clearance?

MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS received FDA 510(k) clearance on 2004-12-21, under 510(k) number K043130.

Who is the listed applicant for MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS?

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 MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS?

The FDA product code for MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS is CAZ.

Related Clinical Trials

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.

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.

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Related Devices (Code: CAZ)

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.

Official Source

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

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