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FDA 510(k)

HOOD, OPERATING, SURGICAL

K-Number: K904969 · 1990-12-12

ApplicantChicago Assoc. For Retarded Citizens
Decision Date1990-12-12
Product CodeFXY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOOD, OPERATING, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Chicago Assoc. For Retarded Citizens. It received FDA 510(k) clearance on 1990-12-12 under 510(k) number K904969. 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 HOOD, OPERATING, SURGICAL?

HOOD, OPERATING, SURGICAL is a medical device that received FDA 510(k) clearance on 1990-12-12. The listed applicant is Chicago Assoc. For Retarded Citizens. The 510(k) number is K904969.

When did HOOD, OPERATING, SURGICAL receive FDA 510(k) clearance?

HOOD, OPERATING, SURGICAL received FDA 510(k) clearance on 1990-12-12, under 510(k) number K904969.

Who is the listed applicant for HOOD, OPERATING, SURGICAL?

The FDA 510(k) record lists Chicago Assoc. For Retarded Citizens as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOOD, OPERATING, SURGICAL?

The FDA product code for HOOD, OPERATING, SURGICAL is FXY.

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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 CorporationK904276DISPOSABLE BEARD COVERAnago, Inc.K903533STERI-SHIELDBiomedical Devices, Inc.K902677STERI-SHIELDBiomedical Devices, Inc.K880431CARETEX SURGEON'S HOODSJames River Corp.

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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