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FDA 510(k)

BUSSE BAC/SHIELD

K-Number: K902297 · 1990-08-17

ApplicantBusse Hospital Disposables, Inc.
Decision Date1990-08-17
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BUSSE BAC/SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K902297. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUSSE BAC/SHIELD?

BUSSE BAC/SHIELD is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K902297.

When did BUSSE BAC/SHIELD receive FDA 510(k) clearance?

BUSSE BAC/SHIELD received FDA 510(k) clearance on 1990-08-17, under 510(k) number K902297.

Who is the listed applicant for BUSSE BAC/SHIELD?

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

What is the FDA product code for BUSSE BAC/SHIELD?

The FDA product code for BUSSE BAC/SHIELD is BSY.

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Other records listing Busse Hospital Disposables, 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.

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEK093909BUSSE SURGICAL DRAPES IVK092212BUSSE SURGICAL DRAPES IIIK082297BUSSE SURGICAL DRAPEK073222MODIFICATION TO:SPECIALTY NEEDLESK070465BUSSE EPIDURAL CATHETER

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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