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FDA 510(k)

BARRIER & FACE MASK WITH INNER FACING

K-Number: K791719 · 1979-10-04

ApplicantSurgikos, Inc.
Decision Date1979-10-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER & FACE MASK WITH INNER FACING is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791719. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARRIER & FACE MASK WITH INNER FACING?

BARRIER & FACE MASK WITH INNER FACING is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Surgikos, Inc.. The 510(k) number is K791719.

When did BARRIER & FACE MASK WITH INNER FACING receive FDA 510(k) clearance?

BARRIER & FACE MASK WITH INNER FACING received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791719.

Who is the listed applicant for BARRIER & FACE MASK WITH INNER FACING?

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

What is the FDA product code for BARRIER & FACE MASK WITH INNER FACING?

The FDA product code for BARRIER & FACE MASK WITH INNER FACING is KKX.

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Other records listing Surgikos, 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: KKX)

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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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