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FDA 510(k)

BARRIER UNIVERSAL SHEET

K-Number: K760933 · 1976-11-11

ApplicantSurgikos, Inc.
Decision Date1976-11-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER UNIVERSAL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1976-11-11 under 510(k) number K760933. 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 UNIVERSAL SHEET?

BARRIER UNIVERSAL SHEET is a medical device that received FDA 510(k) clearance on 1976-11-11. The listed applicant is Surgikos, Inc.. The 510(k) number is K760933.

When did BARRIER UNIVERSAL SHEET receive FDA 510(k) clearance?

BARRIER UNIVERSAL SHEET received FDA 510(k) clearance on 1976-11-11, under 510(k) number K760933.

Who is the listed applicant for BARRIER UNIVERSAL SHEET?

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 UNIVERSAL SHEET?

The FDA product code for BARRIER UNIVERSAL SHEET 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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