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FDA 510(k)

BARRIER FASHION BONNET

K-Number: K760865 · 1976-11-03

ApplicantSurgikos, Inc.
Decision Date1976-11-03
Product CodeFXY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER FASHION BONNET is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1976-11-03 under 510(k) number K760865. The device is classified under product code FXY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARRIER FASHION BONNET?

BARRIER FASHION BONNET is a medical device that received FDA 510(k) clearance on 1976-11-03. The listed applicant is Surgikos, Inc.. The 510(k) number is K760865.

When did BARRIER FASHION BONNET receive FDA 510(k) clearance?

BARRIER FASHION BONNET received FDA 510(k) clearance on 1976-11-03, under 510(k) number K760865.

Who is the listed applicant for BARRIER FASHION BONNET?

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 FASHION BONNET?

The FDA product code for BARRIER FASHION BONNET is FXY.

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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: FXY)

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.

K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbHK200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverStryker CorporationK904969HOOD, OPERATING, SURGICALChicago Assoc. For Retarded CitizensK904276DISPOSABLE BEARD COVERAnago, Inc.K903533STERI-SHIELDBiomedical Devices, Inc.K902677STERI-SHIELDBiomedical Devices, Inc.

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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