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FDA 510(k)

SURGIFORM ANATOMICAL MALAR

K-Number: K964443 · 1996-12-20

ApplicantSurgical Technology Laboratories, Inc.
Decision Date1996-12-20
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIFORM ANATOMICAL MALAR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K964443. 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 SURGIFORM ANATOMICAL MALAR?

SURGIFORM ANATOMICAL MALAR is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K964443.

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

SURGIFORM ANATOMICAL MALAR received FDA 510(k) clearance on 1996-12-20, under 510(k) number K964443.

Who is the listed applicant for SURGIFORM ANATOMICAL MALAR?

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

What is the FDA product code for SURGIFORM ANATOMICAL MALAR?

The FDA product code for SURGIFORM ANATOMICAL MALAR is LZK.

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Other records listing Surgical Technology Laboratories, 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.

K170582Saf-T-Vac Smoke and Fluid EvacuatorK021889SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)K983754STANDARD CHINK983755NASAL DORSAL SERIESK983756SURGIFORM ANATOMICAL MALARK840835STRAITH DRAIN INSERTER

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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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