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FDA 510(k)

MODIFICATION TO: PLEXALONG SETS

K-Number: K042979 · 2004-12-21

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

Device Summary

MODIFICATION TO: PLEXALONG 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 K042979. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: PLEXALONG SETS?

MODIFICATION TO: PLEXALONG 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 K042979.

When did MODIFICATION TO: PLEXALONG SETS receive FDA 510(k) clearance?

MODIFICATION TO: PLEXALONG SETS received FDA 510(k) clearance on 2004-12-21, under 510(k) number K042979.

Who is the listed applicant for MODIFICATION TO: PLEXALONG 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: PLEXALONG SETS?

The FDA product code for MODIFICATION TO: PLEXALONG SETS is BSP.

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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 IVK053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETK053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPK043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS

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Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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