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FDA 510(k)

Medline Anti-Fog Solution

K-Number: K152948 · 2016-02-04

Decision Date2016-02-04
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152948. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Anti-Fog Solution?

Medline Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K152948.

When did Medline Anti-Fog Solution receive FDA 510(k) clearance?

Medline Anti-Fog Solution received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152948.

Who is the listed applicant for Medline Anti-Fog Solution?

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

What is the FDA product code for Medline Anti-Fog Solution?

The FDA product code for Medline Anti-Fog Solution is OCT.

Related Clinical Trials

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.

Other records listing Medline Industries, 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: OCT)

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.

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.