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FDA 510(k)

LIFEMASK FACE SHIELD

K-Number: K953824 · 1995-09-19

ApplicantCarefree Trading, Inc.
Decision Date1995-09-19
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFEMASK FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Carefree Trading, Inc.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K953824. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEMASK FACE SHIELD?

LIFEMASK FACE SHIELD is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Carefree Trading, Inc.. The 510(k) number is K953824.

When did LIFEMASK FACE SHIELD receive FDA 510(k) clearance?

LIFEMASK FACE SHIELD received FDA 510(k) clearance on 1995-09-19, under 510(k) number K953824.

Who is the listed applicant for LIFEMASK FACE SHIELD?

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

What is the FDA product code for LIFEMASK FACE SHIELD?

The FDA product code for LIFEMASK FACE SHIELD is BTM.

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 Carefree Trading, 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.

K954426CPR LIFE MASK COMPACT BARRIER

Related Devices (Code: BTM)

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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