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FDA 510(k)

AQUA-GARD WATERPROOF WOUND PATCH

K-Number: K905022 · 1991-02-11

ApplicantBellhouse Medical, Inc.
Decision Date1991-02-11
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AQUA-GARD WATERPROOF WOUND PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Bellhouse Medical, Inc.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905022. 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 AQUA-GARD WATERPROOF WOUND PATCH?

AQUA-GARD WATERPROOF WOUND PATCH is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Bellhouse Medical, Inc.. The 510(k) number is K905022.

When did AQUA-GARD WATERPROOF WOUND PATCH receive FDA 510(k) clearance?

AQUA-GARD WATERPROOF WOUND PATCH received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905022.

Who is the listed applicant for AQUA-GARD WATERPROOF WOUND PATCH?

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

What is the FDA product code for AQUA-GARD WATERPROOF WOUND PATCH?

The FDA product code for AQUA-GARD WATERPROOF WOUND PATCH is KGX.

Related Clinical Trials

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Other records listing Bellhouse Medical, 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.

K901228MULTI-STRIPK862302BLOOD PLATELET ASSAY METHOD & APPARATUS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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