STERILE WATER FOR INHALATION, USP— 510(k) K972467

Substantially Equivalent

Holopack International, LP

FDA 510(k) clearance K972467 for STERILE WATER FOR INHALATION, USP, Substantially Equivalent on 1997-08-28. Applicant: Holopack International, LP.

Clearance details

Applicant: Holopack International, LP
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1997-07-01
Decision date: 1997-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.