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FDA 510(k)

ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT

K-Number: K992991 · 2000-01-27

ApplicantAtrium Medical Corp.
Decision Date2000-01-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2000-01-27 under 510(k) number K992991. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT?

ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Atrium Medical Corp.. The 510(k) number is K992991.

When did ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT receive FDA 510(k) clearance?

ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT received FDA 510(k) clearance on 2000-01-27, under 510(k) number K992991.

Who is the listed applicant for ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT?

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

What is the FDA product code for ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT?

The FDA product code for ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT is FTL.

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Related Devices (Code: FTL)

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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