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FDA 510(k)

PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY

K-Number: K080654 · 2008-05-08

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2008-05-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY 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 2008-05-08 under 510(k) number K080654. 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'S KIT FOR BALLOON AIDED LAPAROSCOPY?

PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY is a medical device that received FDA 510(k) clearance on 2008-05-08. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K080654.

When did PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY receive FDA 510(k) clearance?

PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY received FDA 510(k) clearance on 2008-05-08, under 510(k) number K080654.

Who is the listed applicant for PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY?

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'S KIT FOR BALLOON AIDED LAPAROSCOPY?

The FDA product code for PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY 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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