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FDA 510(k)

LINISTAIN SLS

K-Number: K890984 · 1989-04-04

ApplicantShandon, Inc.
Decision Date1989-04-04
Product CodeKIO
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

LINISTAIN SLS is the device name listed in this FDA 510(k) record. The listed applicant is Shandon, Inc.. It received FDA 510(k) clearance on 1989-04-04 under 510(k) number K890984. The device is classified under product code KIO. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINISTAIN SLS?

LINISTAIN SLS is a medical device that received FDA 510(k) clearance on 1989-04-04. The listed applicant is Shandon, Inc.. The 510(k) number is K890984.

When did LINISTAIN SLS receive FDA 510(k) clearance?

LINISTAIN SLS received FDA 510(k) clearance on 1989-04-04, under 510(k) number K890984.

Who is the listed applicant for LINISTAIN SLS?

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

What is the FDA product code for LINISTAIN SLS?

The FDA product code for LINISTAIN SLS is KIO.

Related Clinical Trials

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Other records listing Shandon, 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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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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