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FDA 510(k)

FLEXI-TRAK(TM) ANCHORING DEVICE

K-Number: K905128 · 1990-11-29

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1990-11-29
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXI-TRAK(TM) ANCHORING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K905128. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-TRAK(TM) ANCHORING DEVICE?

FLEXI-TRAK(TM) ANCHORING DEVICE is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K905128.

When did FLEXI-TRAK(TM) ANCHORING DEVICE receive FDA 510(k) clearance?

FLEXI-TRAK(TM) ANCHORING DEVICE received FDA 510(k) clearance on 1990-11-29, under 510(k) number K905128.

Who is the listed applicant for FLEXI-TRAK(TM) ANCHORING DEVICE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXI-TRAK(TM) ANCHORING DEVICE?

The FDA product code for FLEXI-TRAK(TM) ANCHORING DEVICE is KNY.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

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Related Devices (Code: KNY)

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

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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