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FDA 510(k)

FISSO HOLDING SYSTEM

K-Number: K070509 · 2007-03-22

ApplicantBaitella AG
Decision Date2007-03-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FISSO HOLDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baitella AG. It received FDA 510(k) clearance on 2007-03-22 under 510(k) number K070509. 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 FISSO HOLDING SYSTEM?

FISSO HOLDING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-22. The listed applicant is Baitella AG. The 510(k) number is K070509.

When did FISSO HOLDING SYSTEM receive FDA 510(k) clearance?

FISSO HOLDING SYSTEM received FDA 510(k) clearance on 2007-03-22, under 510(k) number K070509.

Who is the listed applicant for FISSO HOLDING SYSTEM?

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

What is the FDA product code for FISSO HOLDING SYSTEM?

The FDA product code for FISSO HOLDING SYSTEM is GCJ.

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Related Devices (Code: GCJ)

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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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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