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FDA 510(k)

SHAMPAINE RADI-OP MODEL 1700RC

K-Number: K860620 · 1986-04-08

ApplicantSmith & Nephew, Inc.
Decision Date1986-04-08
Product CodeKXJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHAMPAINE RADI-OP MODEL 1700RC is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1986-04-08 under 510(k) number K860620. The device is classified under product code KXJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAMPAINE RADI-OP MODEL 1700RC?

SHAMPAINE RADI-OP MODEL 1700RC is a medical device that received FDA 510(k) clearance on 1986-04-08. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K860620.

When did SHAMPAINE RADI-OP MODEL 1700RC receive FDA 510(k) clearance?

SHAMPAINE RADI-OP MODEL 1700RC received FDA 510(k) clearance on 1986-04-08, under 510(k) number K860620.

Who is the listed applicant for SHAMPAINE RADI-OP MODEL 1700RC?

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

What is the FDA product code for SHAMPAINE RADI-OP MODEL 1700RC?

The FDA product code for SHAMPAINE RADI-OP MODEL 1700RC is KXJ.

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Other records listing Smith & Nephew, 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.

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Related Devices (Code: KXJ)

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.

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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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