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FDA 510(k)

IMPLANT LOCATION SOFTWARE, MODEL 0.1.0

K-Number: K050341 · 2005-03-29

Decision Date2005-03-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Technologies, Ltd.. It received FDA 510(k) clearance on 2005-03-29 under 510(k) number K050341. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT LOCATION SOFTWARE, MODEL 0.1.0?

IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 is a medical device that received FDA 510(k) clearance on 2005-03-29. The listed applicant is Tactile Technologies, Ltd.. The 510(k) number is K050341.

When did IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 receive FDA 510(k) clearance?

IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 received FDA 510(k) clearance on 2005-03-29, under 510(k) number K050341.

Who is the listed applicant for IMPLANT LOCATION SOFTWARE, MODEL 0.1.0?

The FDA 510(k) record lists Tactile Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT LOCATION SOFTWARE, MODEL 0.1.0?

The FDA product code for IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 is LLZ.

Related Clinical Trials

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.

Other records listing Tactile Technologies, Ltd. 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.

Related Devices (Code: LLZ)

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.

Official Source

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