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FDA 510(k)

PACKAGING TRAY AND COMPONENTS

K-Number: K040707 · 2004-04-16

ApplicantVygon Us, LLC
Decision Date2004-04-16
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PACKAGING TRAY AND COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Us, LLC. It received FDA 510(k) clearance on 2004-04-16 under 510(k) number K040707. 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 PACKAGING TRAY AND COMPONENTS?

PACKAGING TRAY AND COMPONENTS is a medical device that received FDA 510(k) clearance on 2004-04-16. The listed applicant is Vygon Us, LLC. The 510(k) number is K040707.

When did PACKAGING TRAY AND COMPONENTS receive FDA 510(k) clearance?

PACKAGING TRAY AND COMPONENTS received FDA 510(k) clearance on 2004-04-16, under 510(k) number K040707.

Who is the listed applicant for PACKAGING TRAY AND COMPONENTS?

The FDA 510(k) record lists Vygon Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACKAGING TRAY AND COMPONENTS?

The FDA product code for PACKAGING TRAY AND COMPONENTS is FRG.

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Other records listing Vygon Us, LLC 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.

K052475VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERSK033704MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS

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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