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FDA 510(k)

BOUNDARY STERILIZATION WRAP

K-Number: K811819 · 1981-08-04

ApplicantThe Buckeye Cellulose Corp.
Decision Date1981-08-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BOUNDARY STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is The Buckeye Cellulose Corp.. It received FDA 510(k) clearance on 1981-08-04 under 510(k) number K811819. 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 BOUNDARY STERILIZATION WRAP?

BOUNDARY STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1981-08-04. The listed applicant is The Buckeye Cellulose Corp.. The 510(k) number is K811819.

When did BOUNDARY STERILIZATION WRAP receive FDA 510(k) clearance?

BOUNDARY STERILIZATION WRAP received FDA 510(k) clearance on 1981-08-04, under 510(k) number K811819.

Who is the listed applicant for BOUNDARY STERILIZATION WRAP?

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

What is the FDA product code for BOUNDARY STERILIZATION WRAP?

The FDA product code for BOUNDARY STERILIZATION WRAP is FRG.

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Other records listing The Buckeye Cellulose Corp. 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.

K822925BOUNDARY SINGLE-USE GOWNSK823173ARRIRM SCRUB BRUSH/SPONGEK821564BOUNDARY PROCESS CHANGEK820758BOUNDARY SINGLE-USE CRANIOTOMY SHEETK820116BOUNDARYK813450BOUNDARY SINGLE-USE DRAPES

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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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