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FDA 510(k)

ELASTIC ADHESIVE BANDAGE

K-Number: K910436 · 1991-03-19

ApplicantByron Medical
Decision Date1991-03-19
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELASTIC ADHESIVE BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K910436. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELASTIC ADHESIVE BANDAGE?

ELASTIC ADHESIVE BANDAGE is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Byron Medical. The 510(k) number is K910436.

When did ELASTIC ADHESIVE BANDAGE receive FDA 510(k) clearance?

ELASTIC ADHESIVE BANDAGE received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910436.

Who is the listed applicant for ELASTIC ADHESIVE BANDAGE?

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 ELASTIC ADHESIVE BANDAGE?

The FDA product code for ELASTIC ADHESIVE BANDAGE is KGX.

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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: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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