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FDA 510(k)

EDGE PROTECTOR, BARRIER

K-Number: K790306 · 1979-02-22

ApplicantSurgikos, Inc.
Decision Date1979-02-22
Product CodeKGW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EDGE PROTECTOR, BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-02-22 under 510(k) number K790306. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDGE PROTECTOR, BARRIER?

EDGE PROTECTOR, BARRIER is a medical device that received FDA 510(k) clearance on 1979-02-22. The listed applicant is Surgikos, Inc.. The 510(k) number is K790306.

When did EDGE PROTECTOR, BARRIER receive FDA 510(k) clearance?

EDGE PROTECTOR, BARRIER received FDA 510(k) clearance on 1979-02-22, under 510(k) number K790306.

Who is the listed applicant for EDGE PROTECTOR, BARRIER?

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 EDGE PROTECTOR, BARRIER?

The FDA product code for EDGE PROTECTOR, BARRIER is KGW.

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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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPE

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Related Devices (Code: KGW)

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

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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