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FDA 510(k)

TECNOL SPLASHGUARD

K-Number: K934842 · 1994-03-09

ApplicantTecnol Medical Products, Inc.
Decision Date1994-03-09
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECNOL SPLASHGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1994-03-09 under 510(k) number K934842. 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 TECNOL SPLASHGUARD?

TECNOL SPLASHGUARD is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K934842.

When did TECNOL SPLASHGUARD receive FDA 510(k) clearance?

TECNOL SPLASHGUARD received FDA 510(k) clearance on 1994-03-09, under 510(k) number K934842.

Who is the listed applicant for TECNOL SPLASHGUARD?

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

What is the FDA product code for TECNOL SPLASHGUARD?

The FDA product code for TECNOL SPLASHGUARD is LYU.

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Other records listing Tecnol Medical Products, 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: 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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