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FDA 510(k)

SAM FACIAL IMPLANT

K-Number: K961210 · 1996-06-19

ApplicantW. L. Gore & Associates, Inc.
Decision Date1996-06-19
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAM FACIAL IMPLANT 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 1996-06-19 under 510(k) number K961210. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAM FACIAL IMPLANT?

SAM FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1996-06-19. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K961210.

When did SAM FACIAL IMPLANT receive FDA 510(k) clearance?

SAM FACIAL IMPLANT received FDA 510(k) clearance on 1996-06-19, under 510(k) number K961210.

Who is the listed applicant for SAM FACIAL IMPLANT?

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 SAM FACIAL IMPLANT?

The FDA product code for SAM FACIAL IMPLANT is LZK.

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

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLC

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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