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FDA 510(k)

LIMITED REUSE ARTHROSCOPIC BLADES

K-Number: K955914 · 1996-02-08

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1996-02-08
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIMITED REUSE ARTHROSCOPIC BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K955914. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIMITED REUSE ARTHROSCOPIC BLADES?

LIMITED REUSE ARTHROSCOPIC BLADES is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K955914.

When did LIMITED REUSE ARTHROSCOPIC BLADES receive FDA 510(k) clearance?

LIMITED REUSE ARTHROSCOPIC BLADES received FDA 510(k) clearance on 1996-02-08, under 510(k) number K955914.

Who is the listed applicant for LIMITED REUSE ARTHROSCOPIC BLADES?

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

What is the FDA product code for LIMITED REUSE ARTHROSCOPIC BLADES?

The FDA product code for LIMITED REUSE ARTHROSCOPIC BLADES is HRX.

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Other records listing Smith & Nephew Dyonics, Inc. 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.

K954627ECTRA II LIGAMENT RELEASE SYSTEMK954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADESK953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESK953387ECTRA LIGAMENT RELEASE SYSTEMK945182DYONICS FIXATION SCREWSK936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

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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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