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FDA 510(k)

ZARA ZONE IV MALAR IMPLANT MODIFICATION

K-Number: K934233 · 1994-02-03

ApplicantByron Medical
Decision Date1994-02-03
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZARA ZONE IV MALAR IMPLANT MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K934233. 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 ZARA ZONE IV MALAR IMPLANT MODIFICATION?

ZARA ZONE IV MALAR IMPLANT MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Byron Medical. The 510(k) number is K934233.

When did ZARA ZONE IV MALAR IMPLANT MODIFICATION receive FDA 510(k) clearance?

ZARA ZONE IV MALAR IMPLANT MODIFICATION received FDA 510(k) clearance on 1994-02-03, under 510(k) number K934233.

Who is the listed applicant for ZARA ZONE IV MALAR IMPLANT MODIFICATION?

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 ZARA ZONE IV MALAR IMPLANT MODIFICATION?

The FDA product code for ZARA ZONE IV MALAR IMPLANT MODIFICATION 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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