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FDA 510(k)

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M

K-Number: K910783 · 1991-04-02

ApplicantSmith & Nephew Equipment Group
Decision Date1991-04-02
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Equipment Group. It received FDA 510(k) clearance on 1991-04-02 under 510(k) number K910783. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M?

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M is a medical device that received FDA 510(k) clearance on 1991-04-02. The listed applicant is Smith & Nephew Equipment Group. The 510(k) number is K910783.

When did SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M receive FDA 510(k) clearance?

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M received FDA 510(k) clearance on 1991-04-02, under 510(k) number K910783.

Who is the listed applicant for SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M?

The FDA 510(k) record lists Smith & Nephew Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M?

The FDA product code for SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M is BWN.

Related Clinical Trials

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Other records listing Smith & Nephew Equipment Group 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.

K904965SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4

Related Devices (Code: BWN)

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.

K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK902865BAUMER SURGICAL TABLESds Dental, Inc.K884558IOP ADJUSTABLE STIRRUPMend Technologies, 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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