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FDA 510(k)

ESOPHAGEAL DILATOR SET

K-Number: K842679 · 1984-10-02

ApplicantMill-Rose Laboratory
Decision Date1984-10-02
Product CodeFAT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1984-10-02 under 510(k) number K842679. The device is classified under product code FAT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL DILATOR SET?

ESOPHAGEAL DILATOR SET is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K842679.

When did ESOPHAGEAL DILATOR SET receive FDA 510(k) clearance?

ESOPHAGEAL DILATOR SET received FDA 510(k) clearance on 1984-10-02, under 510(k) number K842679.

Who is the listed applicant for ESOPHAGEAL DILATOR SET?

The FDA 510(k) record lists Mill-Rose Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOPHAGEAL DILATOR SET?

The FDA product code for ESOPHAGEAL DILATOR SET is FAT.

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Other records listing Mill-Rose Laboratory 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.

K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

Related Devices (Code: FAT)

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.

K983220STRYKER INFRAVISION ESOPHAGEAL KITStryker EndoscopyK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.K901425PYLORIC BALLOON DILATORTelemed Systems, Inc.K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIEDacomed Corp.K780471GASTRIC LAVAGE KITGaymar Industries, 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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