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FDA 510(k)

ULTRAFIT LINERS

K-Number: K954314 · 1995-12-28

ApplicantStahmer Weston Scientific
Decision Date1995-12-28
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRAFIT LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Stahmer Weston Scientific. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K954314. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFIT LINERS?

ULTRAFIT LINERS is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Stahmer Weston Scientific. The 510(k) number is K954314.

When did ULTRAFIT LINERS receive FDA 510(k) clearance?

ULTRAFIT LINERS received FDA 510(k) clearance on 1995-12-28, under 510(k) number K954314.

Who is the listed applicant for ULTRAFIT LINERS?

The FDA 510(k) record lists Stahmer Weston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAFIT LINERS?

The FDA product code for ULTRAFIT LINERS is LYU.

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Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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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