STERILE ISOTONIC SALINE & STERILE WATER— 510(k) K954442

Substantially Equivalent

Medcare Custom Packaging, Inc.

FDA 510(k) clearance K954442 for STERILE ISOTONIC SALINE & STERILE WATER, Substantially Equivalent on 1995-12-21. Applicant: Medcare Custom Packaging, Inc..

Clearance details

Applicant: Medcare Custom Packaging, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1995-09-25
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Swanzey, NH, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.