FDA 510(k)

OP-D-OP II

K-Number: K945098 · 1995-02-28

Decision Date1995-02-28

Product CodeLYU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OP-D-OP II is the device name listed in this FDA 510(k) record. The listed applicant is Op-D-Op Visor Shields, Inc.. It received FDA 510(k) clearance on 1995-02-28 under 510(k) number K945098. 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 OP-D-OP II?

OP-D-OP II is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Op-D-Op Visor Shields, Inc.. The 510(k) number is K945098.

When did OP-D-OP II receive FDA 510(k) clearance?

OP-D-OP II received FDA 510(k) clearance on 1995-02-28, under 510(k) number K945098.

Who is the listed applicant for OP-D-OP II?

The FDA 510(k) record lists Op-D-Op Visor Shields, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OP-D-OP II?

The FDA product code for OP-D-OP II is LYU.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.