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FDA 510(k)

ANTIFOG

K-Number: K934347 · 1994-01-21

ApplicantNorpak Mfg., Inc.
Decision Date1994-01-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANTIFOG is the device name listed in this FDA 510(k) record. The listed applicant is Norpak Mfg., Inc.. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K934347. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIFOG?

ANTIFOG is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Norpak Mfg., Inc.. The 510(k) number is K934347.

When did ANTIFOG receive FDA 510(k) clearance?

ANTIFOG received FDA 510(k) clearance on 1994-01-21, under 510(k) number K934347.

Who is the listed applicant for ANTIFOG?

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

What is the FDA product code for ANTIFOG?

The FDA product code for ANTIFOG is GCJ.

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.

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Other records listing Norpak Mfg., 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.

K896835ALCOHOL PREP AND POVIDONE-IODINE PREP

Related Devices (Code: GCJ)

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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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.

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