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FDA 510(k)

NEOTRACT ANCHOR SYSTEM MODEL TAS400

K-Number: K102028 · 2010-08-04

ApplicantNeotract, Inc.
Decision Date2010-08-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEOTRACT ANCHOR SYSTEM MODEL TAS400 is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2010-08-04 under 510(k) number K102028. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOTRACT ANCHOR SYSTEM MODEL TAS400?

NEOTRACT ANCHOR SYSTEM MODEL TAS400 is a medical device that received FDA 510(k) clearance on 2010-08-04. The listed applicant is Neotract, Inc.. The 510(k) number is K102028.

When did NEOTRACT ANCHOR SYSTEM MODEL TAS400 receive FDA 510(k) clearance?

NEOTRACT ANCHOR SYSTEM MODEL TAS400 received FDA 510(k) clearance on 2010-08-04, under 510(k) number K102028.

Who is the listed applicant for NEOTRACT ANCHOR SYSTEM MODEL TAS400?

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

What is the FDA product code for NEOTRACT ANCHOR SYSTEM MODEL TAS400?

The FDA product code for NEOTRACT ANCHOR SYSTEM MODEL TAS400 is GAT.

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Related Devices (Code: GAT)

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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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