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FDA 510(k)

MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX

K-Number: K011997 · 2001-07-10

ApplicantPajunk GmbH
Decision Date2001-07-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2001-07-10 under 510(k) number K011997. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX?

MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Pajunk GmbH. The 510(k) number is K011997.

When did MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX receive FDA 510(k) clearance?

MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011997.

Who is the listed applicant for MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX?

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 MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX?

The FDA product code for MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX is GCJ.

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Other records listing Pajunk GmbH as applicant

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Related Devices (Code: GCJ)

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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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