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FDA 510(k)

SALINE DRESSING

K-Number: K952948 · 1995-08-16

ApplicantBusse Hospital Disposables, Inc.
Decision Date1995-08-16
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SALINE 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 1995-08-16 under 510(k) number K952948. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SALINE DRESSING?

SALINE DRESSING is a medical device that received FDA 510(k) clearance on 1995-08-16. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K952948.

When did SALINE DRESSING receive FDA 510(k) clearance?

SALINE DRESSING received FDA 510(k) clearance on 1995-08-16, under 510(k) number K952948.

Who is the listed applicant for SALINE 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 SALINE DRESSING?

The FDA product code for SALINE DRESSING is FRO. This falls under the Anesthesiology category.

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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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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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