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FDA 510(k)

ELASTIC ADHESIVE BANDAGES(STERILE)

K-Number: K801794 · 1980-08-13

ApplicantSmith & Nephew, Inc.
Decision Date1980-08-13
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELASTIC ADHESIVE BANDAGES(STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801794. 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 BANDAGES(STERILE)?

ELASTIC ADHESIVE BANDAGES(STERILE) is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K801794.

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

ELASTIC ADHESIVE BANDAGES(STERILE) received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801794.

Who is the listed applicant for ELASTIC ADHESIVE BANDAGES(STERILE)?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELASTIC ADHESIVE BANDAGES(STERILE)?

The FDA product code for ELASTIC ADHESIVE BANDAGES(STERILE) is KGX.

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Other records listing Smith & Nephew, 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.

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View all 509 devices →

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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