STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291— 510(k) K981905

Substantially Equivalent

Acu-Pak

FDA 510(k) clearance K981905 for STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291, Substantially Equivalent on 1998-08-18. Applicant: Acu-Pak.

Clearance details

Applicant: Acu-Pak
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1998-06-01
Decision date: 1998-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Londonderry, NH, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.