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FDA 510(k)

DENTAL STERLIZATION TRAY/CASSETTE

K-Number: K983223 · 1999-01-14

ApplicantBrasseler USA I, L.P.
Decision Date1999-01-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DENTAL STERLIZATION TRAY/CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Brasseler USA I, L.P.. It received FDA 510(k) clearance on 1999-01-14 under 510(k) number K983223. 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 DENTAL STERLIZATION TRAY/CASSETTE?

DENTAL STERLIZATION TRAY/CASSETTE is a medical device that received FDA 510(k) clearance on 1999-01-14. The listed applicant is Brasseler USA I, L.P.. The 510(k) number is K983223.

When did DENTAL STERLIZATION TRAY/CASSETTE receive FDA 510(k) clearance?

DENTAL STERLIZATION TRAY/CASSETTE received FDA 510(k) clearance on 1999-01-14, under 510(k) number K983223.

Who is the listed applicant for DENTAL STERLIZATION TRAY/CASSETTE?

The FDA 510(k) record lists Brasseler USA I, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL STERLIZATION TRAY/CASSETTE?

The FDA product code for DENTAL STERLIZATION TRAY/CASSETTE is FRG.

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Other records listing Brasseler USA I, L.P. as applicant

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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

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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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