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FDA 510(k)

ROLL-A-SET

K-Number: K810918 · 1981-05-21

ApplicantPrinciple Business Ent.
Decision Date1981-05-21
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROLL-A-SET is the device name listed in this FDA 510(k) record. The listed applicant is Principle Business Ent.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K810918. 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 ROLL-A-SET?

ROLL-A-SET is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Principle Business Ent.. The 510(k) number is K810918.

When did ROLL-A-SET receive FDA 510(k) clearance?

ROLL-A-SET received FDA 510(k) clearance on 1981-05-21, under 510(k) number K810918.

Who is the listed applicant for ROLL-A-SET?

The FDA 510(k) record lists Principle Business Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROLL-A-SET?

The FDA product code for ROLL-A-SET is FRG.

Other records listing Principle Business Ent. 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.

K843869TRANQUILITYK810544INCONTINENT PAD & BELT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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