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FDA 510(k)

PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS

K-Number: K090631 · 2009-04-16

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2009-04-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2009-04-16 under 510(k) number K090631. 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 PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS?

PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-04-16. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K090631.

When did PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS receive FDA 510(k) clearance?

PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS received FDA 510(k) clearance on 2009-04-16, under 510(k) number K090631.

Who is the listed applicant for PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS?

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

What is the FDA product code for PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS?

The FDA product code for PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS is 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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