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FDA 510(k)

ENDOSOPIC STENE MANIPULATING BALLOON

K-Number: K850489 · 1985-04-22

ApplicantMill-Rose Laboratory
Decision Date1985-04-22
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSOPIC STENE MANIPULATING BALLOON 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 1985-04-22 under 510(k) number K850489. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSOPIC STENE MANIPULATING BALLOON?

ENDOSOPIC STENE MANIPULATING BALLOON is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K850489.

When did ENDOSOPIC STENE MANIPULATING BALLOON receive FDA 510(k) clearance?

ENDOSOPIC STENE MANIPULATING BALLOON received FDA 510(k) clearance on 1985-04-22, under 510(k) number K850489.

Who is the listed applicant for ENDOSOPIC STENE MANIPULATING BALLOON?

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 ENDOSOPIC STENE MANIPULATING BALLOON?

The FDA product code for ENDOSOPIC STENE MANIPULATING BALLOON is LQR.

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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

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Related Devices (Code: LQR)

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.

K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover Retrieval BasketBoston Scientific Corporation

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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