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FDA 510(k)

RADIO-PLAST

K-Number: K981115 · 1998-06-25

ApplicantSmith & Nephew, Inc.
Decision Date1998-06-25
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIO-PLAST 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 1998-06-25 under 510(k) number K981115. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIO-PLAST?

RADIO-PLAST is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K981115.

When did RADIO-PLAST receive FDA 510(k) clearance?

RADIO-PLAST received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981115.

Who is the listed applicant for RADIO-PLAST?

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 RADIO-PLAST?

The FDA product code for RADIO-PLAST is LHN.

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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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