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FDA 510(k)

STERI-SHIELD

K-Number: K902677 · 1990-08-17

ApplicantBiomedical Devices, Inc.
Decision Date1990-08-17
Product CodeFXY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERI-SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Devices, Inc.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K902677. 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 STERI-SHIELD?

STERI-SHIELD is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Biomedical Devices, Inc.. The 510(k) number is K902677.

When did STERI-SHIELD receive FDA 510(k) clearance?

STERI-SHIELD received FDA 510(k) clearance on 1990-08-17, under 510(k) number K902677.

Who is the listed applicant for STERI-SHIELD?

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

What is the FDA product code for STERI-SHIELD?

The FDA product code for STERI-SHIELD is FXY.

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Other records listing Biomedical Devices, 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.

K955439THE REEL THING (MODIFICATION)K931847BIO-PREP CEMENT RESTRICTORK931846BIO-PREPK925982BMD AIR/OXYGEN BLENDERK903533STERI-SHIELDK830605PUMP PALL AMBULATORY INSULIN INFUSION

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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.K880431CARETEX SURGEON'S HOODSJames River Corp.

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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