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FDA 510(k)

S.A.M. FACIAL IMPLANT W/INTRODUCER

K-Number: K964761 · 1997-01-27

ApplicantW. L. Gore & Associates, Inc.
Decision Date1997-01-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S.A.M. FACIAL IMPLANT W/INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K964761. 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 S.A.M. FACIAL IMPLANT W/INTRODUCER?

S.A.M. FACIAL IMPLANT W/INTRODUCER is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K964761.

When did S.A.M. FACIAL IMPLANT W/INTRODUCER receive FDA 510(k) clearance?

S.A.M. FACIAL IMPLANT W/INTRODUCER received FDA 510(k) clearance on 1997-01-27, under 510(k) number K964761.

Who is the listed applicant for S.A.M. FACIAL IMPLANT W/INTRODUCER?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.A.M. FACIAL IMPLANT W/INTRODUCER?

The FDA product code for S.A.M. FACIAL IMPLANT W/INTRODUCER is FTL.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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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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