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FDA 510(k)

LEUKOFLEX SURGICAL TAPE

K-Number: K843876 · 1985-02-21

ApplicantBeiersdorf, Inc.
Decision Date1985-02-21
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LEUKOFLEX SURGICAL TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Beiersdorf, Inc.. It received FDA 510(k) clearance on 1985-02-21 under 510(k) number K843876. 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 LEUKOFLEX SURGICAL TAPE?

LEUKOFLEX SURGICAL TAPE is a medical device that received FDA 510(k) clearance on 1985-02-21. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K843876.

When did LEUKOFLEX SURGICAL TAPE receive FDA 510(k) clearance?

LEUKOFLEX SURGICAL TAPE received FDA 510(k) clearance on 1985-02-21, under 510(k) number K843876.

Who is the listed applicant for LEUKOFLEX SURGICAL TAPE?

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

What is the FDA product code for LEUKOFLEX SURGICAL TAPE?

The FDA product code for LEUKOFLEX SURGICAL TAPE is KGX.

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Other records listing Beiersdorf, 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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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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