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FDA 510(k)

DURALASTIC ANATOMICAL MALAR IMPLANT

K-Number: K973574 · 1997-10-24

ApplicantHanson Medical, Inc.
Decision Date1997-10-24
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURALASTIC ANATOMICAL MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 1997-10-24 under 510(k) number K973574. 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 DURALASTIC ANATOMICAL MALAR IMPLANT?

DURALASTIC ANATOMICAL MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973574.

When did DURALASTIC ANATOMICAL MALAR IMPLANT receive FDA 510(k) clearance?

DURALASTIC ANATOMICAL MALAR IMPLANT received FDA 510(k) clearance on 1997-10-24, under 510(k) number K973574.

Who is the listed applicant for DURALASTIC ANATOMICAL MALAR IMPLANT?

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

What is the FDA product code for DURALASTIC ANATOMICAL MALAR IMPLANT?

The FDA product code for DURALASTIC ANATOMICAL MALAR IMPLANT is LZK.

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Other records listing Hanson Medical, 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.

K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030808HANSON MEDICAL CALF IMPLANTK030809HANSON MEDICAL GLUTEAL IMPLANT

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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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