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FDA 510(k)

GUARDIAN PEEL POUCHES

K-Number: K803293 · 1981-01-28

ApplicantKimberly-Clark Corp.
Decision Date1981-01-28
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUARDIAN PEEL POUCHES is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K803293. 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 GUARDIAN PEEL POUCHES?

GUARDIAN PEEL POUCHES is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K803293.

When did GUARDIAN PEEL POUCHES receive FDA 510(k) clearance?

GUARDIAN PEEL POUCHES received FDA 510(k) clearance on 1981-01-28, under 510(k) number K803293.

Who is the listed applicant for GUARDIAN PEEL POUCHES?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIAN PEEL POUCHES?

The FDA product code for GUARDIAN PEEL POUCHES is FRG.

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Other records listing Kimberly-Clark Corp. as applicant

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Related Devices (Code: FRG)

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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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