STERILE PHYSIOLOGICAL SALINE/STERILE WATER— 510(k) K943661

Substantially Equivalent

Medcare Custom Packaging, Inc.

FDA 510(k) clearance K943661 for STERILE PHYSIOLOGICAL SALINE/STERILE WATER, Substantially Equivalent on 1995-04-10. Applicant: Medcare Custom Packaging, Inc..

Clearance details

Applicant: Medcare Custom Packaging, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1994-07-28
Decision date: 1995-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: E 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.