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FDA 510(k)

DRESSING CHANGE TRAY

K-Number: K841123 · 1984-04-17

ApplicantMedcare Products
Decision Date1984-04-17
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRESSING CHANGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Products. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K841123. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRESSING CHANGE TRAY?

DRESSING CHANGE TRAY is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Medcare Products. The 510(k) number is K841123.

When did DRESSING CHANGE TRAY receive FDA 510(k) clearance?

DRESSING CHANGE TRAY received FDA 510(k) clearance on 1984-04-17, under 510(k) number K841123.

Who is the listed applicant for DRESSING CHANGE TRAY?

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

What is the FDA product code for DRESSING CHANGE TRAY?

The FDA product code for DRESSING CHANGE TRAY is FRG.

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Other records listing Medcare Products 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.

K841122TRACHEOSTOMY CARE TRAYK841124DIALYSIS TRAYK831374MED CARE PREP RAZORK831663TISSUE FORCEPSK831664PLASTIC THUMB FORCEPSK831665DISPOSABLE NEEDLE HOLDER

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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