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FDA 510(k)

FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000

K-Number: K863753 · 1986-10-30

ApplicantFoundations Plus, Inc.
Decision Date1986-10-30
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Foundations Plus, Inc.. It received FDA 510(k) clearance on 1986-10-30 under 510(k) number K863753. 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 FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000?

FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 is a medical device that received FDA 510(k) clearance on 1986-10-30. The listed applicant is Foundations Plus, Inc.. The 510(k) number is K863753.

When did FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 receive FDA 510(k) clearance?

FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 received FDA 510(k) clearance on 1986-10-30, under 510(k) number K863753.

Who is the listed applicant for FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000?

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

What is the FDA product code for FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000?

The FDA product code for FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 is KGX.

Related Clinical Trials

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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Other records listing Foundations Plus, 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.

K871138FOUNDATIONS PLUS ABDOMINAL BAND 1100K864477FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000K863754FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000

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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