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FDA 510(k)

BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR

K-Number: K863400 · 1986-09-17

ApplicantByron Medical
Decision Date1986-09-17
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1986-09-17 under 510(k) number K863400. 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 BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR?

BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR is a medical device that received FDA 510(k) clearance on 1986-09-17. The listed applicant is Byron Medical. The 510(k) number is K863400.

When did BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR receive FDA 510(k) clearance?

BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR received FDA 510(k) clearance on 1986-09-17, under 510(k) number K863400.

Who is the listed applicant for BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR?

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

What is the FDA product code for BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR?

The FDA product code for BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR is LZK.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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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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