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FDA 510(k)

TACTIPEN

K-Number: K083457 · 2009-02-13

ApplicantHaselmeier GmbH
Decision Date2009-02-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TACTIPEN is the device name listed in this FDA 510(k) record. The listed applicant is Haselmeier GmbH. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K083457. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTIPEN?

TACTIPEN is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Haselmeier GmbH. The 510(k) number is K083457.

When did TACTIPEN receive FDA 510(k) clearance?

TACTIPEN received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083457.

Who is the listed applicant for TACTIPEN?

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

What is the FDA product code for TACTIPEN?

The FDA product code for TACTIPEN is FMF.

Related Clinical Trials

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Other records listing Haselmeier 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.

K082616HASELMEIER PEN 8

Related Devices (Code: FMF)

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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