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FDA 510(k)

HYDROPHILIC FOAM DRESSING

K-Number: K953019 · 1995-09-15

ApplicantBusse Hospital Disposables, Inc.
Decision Date1995-09-15
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYDROPHILIC FOAM DRESSING 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 1995-09-15 under 510(k) number K953019. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYDROPHILIC FOAM DRESSING?

HYDROPHILIC FOAM DRESSING is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K953019.

When did HYDROPHILIC FOAM DRESSING receive FDA 510(k) clearance?

HYDROPHILIC FOAM DRESSING received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953019.

Who is the listed applicant for HYDROPHILIC FOAM DRESSING?

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 HYDROPHILIC FOAM DRESSING?

The FDA product code for HYDROPHILIC FOAM DRESSING is KMF.

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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.

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Related Devices (Code: KMF)

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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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