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FDA 510(k)

COVERLET ADHESIVE DRESSING

K-Number: K940378 · 1994-07-29

ApplicantBeiersdorf, Inc.
Decision Date1994-07-29
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

COVERLET ADHESIVE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Beiersdorf, Inc.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K940378. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COVERLET ADHESIVE DRESSING?

COVERLET ADHESIVE DRESSING is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K940378.

When did COVERLET ADHESIVE DRESSING receive FDA 510(k) clearance?

COVERLET ADHESIVE DRESSING received FDA 510(k) clearance on 1994-07-29, under 510(k) number K940378.

Who is the listed applicant for COVERLET ADHESIVE DRESSING?

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 COVERLET ADHESIVE DRESSING?

The FDA product code for COVERLET ADHESIVE DRESSING 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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