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FDA 510(k)

COMFEEL PROTECTIVE SHEET

K-Number: K820018 · 1982-02-04

ApplicantTelecam Medical Devices
Decision Date1982-02-04
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL PROTECTIVE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Telecam Medical Devices. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820018. 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 COMFEEL PROTECTIVE SHEET?

COMFEEL PROTECTIVE SHEET is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Telecam Medical Devices. The 510(k) number is K820018.

When did COMFEEL PROTECTIVE SHEET receive FDA 510(k) clearance?

COMFEEL PROTECTIVE SHEET received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820018.

Who is the listed applicant for COMFEEL PROTECTIVE SHEET?

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

What is the FDA product code for COMFEEL PROTECTIVE SHEET?

The FDA product code for COMFEEL PROTECTIVE SHEET is KGX.

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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

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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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