PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION— 510(k) K082330

Substantially Equivalent

Primary Care Solutions, Inc.

FDA 510(k) clearance K082330 for PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION, Substantially Equivalent on 2008-10-09. Applicant: Primary Care Solutions, Inc..

Clearance details

Applicant: Primary Care Solutions, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2008-08-14
Decision date: 2008-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zephyrhills, FL, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.