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FDA 510(k)

84E SERIES SINGLE PLY WRAPPER

K-Number: K102864 · 2011-01-14

ApplicantLac Mac, Ltd.
Decision Date2011-01-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

84E SERIES SINGLE PLY WRAPPER is the device name listed in this FDA 510(k) record. The listed applicant is Lac Mac, Ltd.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102864. 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 84E SERIES SINGLE PLY WRAPPER?

84E SERIES SINGLE PLY WRAPPER is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Lac Mac, Ltd.. The 510(k) number is K102864.

When did 84E SERIES SINGLE PLY WRAPPER receive FDA 510(k) clearance?

84E SERIES SINGLE PLY WRAPPER received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102864.

Who is the listed applicant for 84E SERIES SINGLE PLY WRAPPER?

The FDA 510(k) record lists Lac Mac, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 84E SERIES SINGLE PLY WRAPPER?

The FDA product code for 84E SERIES SINGLE PLY WRAPPER is FRG.

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Other records listing Lac Mac, Ltd. 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.

K092344LAC-MAC INNERBLOC LR SURGICAL GOWNSK061491LAC-MAC INNERBLOC O.R. GOWNK032631INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSK030536LAC-MAC LIMITED INNERBLOC O.R. GOWN

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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