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FDA 510(k)

CENTRAL SUPPLY ROOM WRAP

K-Number: K823513 · 1983-01-07

ApplicantJames River Corp.
Decision Date1983-01-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTRAL SUPPLY ROOM WRAP is the device name listed in this FDA 510(k) record. The listed applicant is James River Corp.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823513. 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 CENTRAL SUPPLY ROOM WRAP?

CENTRAL SUPPLY ROOM WRAP is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is James River Corp.. The 510(k) number is K823513.

When did CENTRAL SUPPLY ROOM WRAP receive FDA 510(k) clearance?

CENTRAL SUPPLY ROOM WRAP received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823513.

Who is the listed applicant for CENTRAL SUPPLY ROOM WRAP?

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

What is the FDA product code for CENTRAL SUPPLY ROOM WRAP?

The FDA product code for CENTRAL SUPPLY ROOM WRAP is FRG.

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Other records listing James River 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.

K894505COTOLIN DRAIN SPONGE AND DRESSING SPONGEK894147VISULIN TRANSPARENT ADHESIVE DRESSINGK894034MODIFIED LABELING OF SURGICAL GLOVESK892580CARETOUCH EXAMINATION GLOVESK893939ISOLATION MASKSK890459JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES

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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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