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FDA 510(k)

BUSE STAFF PROTECTION GOWNS AND KITS

K-Number: K941845 · 1995-05-10

ApplicantBusse Hospital Disposables, Inc.
Decision Date1995-05-10
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUSE STAFF PROTECTION GOWNS AND KITS 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 1995-05-10 under 510(k) number K941845. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUSE STAFF PROTECTION GOWNS AND KITS?

BUSE STAFF PROTECTION GOWNS AND KITS is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K941845.

When did BUSE STAFF PROTECTION GOWNS AND KITS receive FDA 510(k) clearance?

BUSE STAFF PROTECTION GOWNS AND KITS received FDA 510(k) clearance on 1995-05-10, under 510(k) number K941845.

Who is the listed applicant for BUSE STAFF PROTECTION GOWNS AND KITS?

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 BUSE STAFF PROTECTION GOWNS AND KITS?

The FDA product code for BUSE STAFF PROTECTION GOWNS AND KITS is FYC.

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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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