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FDA 510(k)

LEUKOPLAST(R) POROUS AND SPORT TAPE

K-Number: K864160 · 1986-11-17

ApplicantBeiersdorf, Inc.
Decision Date1986-11-17
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LEUKOPLAST(R) POROUS AND SPORT 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 1986-11-17 under 510(k) number K864160. 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 LEUKOPLAST(R) POROUS AND SPORT TAPE?

LEUKOPLAST(R) POROUS AND SPORT TAPE is a medical device that received FDA 510(k) clearance on 1986-11-17. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K864160.

When did LEUKOPLAST(R) POROUS AND SPORT TAPE receive FDA 510(k) clearance?

LEUKOPLAST(R) POROUS AND SPORT TAPE received FDA 510(k) clearance on 1986-11-17, under 510(k) number K864160.

Who is the listed applicant for LEUKOPLAST(R) POROUS AND SPORT 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 LEUKOPLAST(R) POROUS AND SPORT TAPE?

The FDA product code for LEUKOPLAST(R) POROUS AND SPORT 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.

K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02K024057CURAD SCAR THERAPYK952526CUTINOVA CAVITYK943363CUTIPLAST STERILK944581CUTINOVA THIN WOUND DRESSINGK935630NORTA

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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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