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FDA 510(k)

ZARA SILICONE BLOCK

K-Number: K913882 · 1992-04-21

ApplicantByron Medical
Decision Date1992-04-21
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ZARA SILICONE BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K913882. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZARA SILICONE BLOCK?

ZARA SILICONE BLOCK is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is Byron Medical. The 510(k) number is K913882.

When did ZARA SILICONE BLOCK receive FDA 510(k) clearance?

ZARA SILICONE BLOCK received FDA 510(k) clearance on 1992-04-21, under 510(k) number K913882.

Who is the listed applicant for ZARA SILICONE BLOCK?

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 SILICONE BLOCK?

The FDA product code for ZARA SILICONE BLOCK is MIB.

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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: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

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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