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FDA 510(k)

ARTHRO-PREP REST W/STAND

K-Number: K812395 · 1981-11-20

Decision Date1981-11-20
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHRO-PREP REST W/STAND is the device name listed in this FDA 510(k) record. The listed applicant is Northwest Surgical Concepts, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K812395. 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 ARTHRO-PREP REST W/STAND?

ARTHRO-PREP REST W/STAND is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Northwest Surgical Concepts, Inc.. The 510(k) number is K812395.

When did ARTHRO-PREP REST W/STAND receive FDA 510(k) clearance?

ARTHRO-PREP REST W/STAND received FDA 510(k) clearance on 1981-11-20, under 510(k) number K812395.

Who is the listed applicant for ARTHRO-PREP REST W/STAND?

The FDA 510(k) record lists Northwest Surgical Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHRO-PREP REST W/STAND?

The FDA product code for ARTHRO-PREP REST W/STAND is BWN.

Related Clinical Trials

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.

Other records listing Northwest Surgical Concepts, 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.

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.

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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