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FDA 510(k)

CATALOG NUMBER 111 (FACESHIELD)

K-Number: K925290 · 1993-07-23

ApplicantAnsley Medical Products, Inc.
Decision Date1993-07-23
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATALOG NUMBER 111 (FACESHIELD) is the device name listed in this FDA 510(k) record. The listed applicant is Ansley Medical Products, Inc.. It received FDA 510(k) clearance on 1993-07-23 under 510(k) number K925290. 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 CATALOG NUMBER 111 (FACESHIELD)?

CATALOG NUMBER 111 (FACESHIELD) is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Ansley Medical Products, Inc.. The 510(k) number is K925290.

When did CATALOG NUMBER 111 (FACESHIELD) receive FDA 510(k) clearance?

CATALOG NUMBER 111 (FACESHIELD) received FDA 510(k) clearance on 1993-07-23, under 510(k) number K925290.

Who is the listed applicant for CATALOG NUMBER 111 (FACESHIELD)?

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

What is the FDA product code for CATALOG NUMBER 111 (FACESHIELD)?

The FDA product code for CATALOG NUMBER 111 (FACESHIELD) is LYU.

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Other records listing Ansley 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.

K932857ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.K924567FOLEY CATHETER TUBE HOLDER NO. 101K924566RESTRAINT, PROTECTIVE N0. 103K924568TUBE, LEAD, AND CORD HOLDER NO. 102

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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