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FDA 510(k)

SALINE SOLUTINE, STERILE

K-Number: K950560 · 1995-05-30

Decision Date1995-05-30
Product CodeIGE
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SALINE SOLUTINE, STERILE 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 1995-05-30 under 510(k) number K950560. The device is classified under product code IGE. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALINE SOLUTINE, STERILE?

SALINE SOLUTINE, STERILE is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K950560.

When did SALINE SOLUTINE, STERILE receive FDA 510(k) clearance?

SALINE SOLUTINE, STERILE received FDA 510(k) clearance on 1995-05-30, under 510(k) number K950560.

Who is the listed applicant for SALINE SOLUTINE, STERILE?

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 SOLUTINE, STERILE?

The FDA product code for SALINE SOLUTINE, STERILE is IGE.

Related Clinical Trials

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.

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.

View all 31 devices →

Related Devices (Code: IGE)

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.

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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