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FDA 510(k)

STERILE WATER FOR INHALATION, USP

K-Number: K972467 · 1997-08-28

ApplicantHolopack International, LP
Decision Date1997-08-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STERILE WATER FOR INHALATION, USP is the device name listed in this FDA 510(k) record. The listed applicant is Holopack International, LP. It received FDA 510(k) clearance on 1997-08-28 under 510(k) number K972467. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE WATER FOR INHALATION, USP?

STERILE WATER FOR INHALATION, USP is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Holopack International, LP. The 510(k) number is K972467.

When did STERILE WATER FOR INHALATION, USP receive FDA 510(k) clearance?

STERILE WATER FOR INHALATION, USP received FDA 510(k) clearance on 1997-08-28, under 510(k) number K972467.

Who is the listed applicant for STERILE WATER FOR INHALATION, USP?

The FDA 510(k) record lists Holopack International, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE WATER FOR INHALATION, USP?

The FDA product code for STERILE WATER FOR INHALATION, USP is CAF.

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Other records listing Holopack International, LP 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.

K9740560.9.% SODIUM CHLORIDE INHALATION SOLUTION, USPK972466SODIUM CHLORIDE INHALATION SOLUTION, USP

Related Devices (Code: CAF)

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

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