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FDA 510(k)

TENSOPLUS LITE

K-Number: K901378 · 1990-06-12

ApplicantSmith & Nephew United, Inc.
Decision Date1990-06-12
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TENSOPLUS LITE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K901378. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENSOPLUS LITE?

TENSOPLUS LITE is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K901378.

When did TENSOPLUS LITE receive FDA 510(k) clearance?

TENSOPLUS LITE received FDA 510(k) clearance on 1990-06-12, under 510(k) number K901378.

Who is the listed applicant for TENSOPLUS LITE?

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

What is the FDA product code for TENSOPLUS LITE?

The FDA product code for TENSOPLUS LITE is NAD.

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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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