SPARTA WET DRESSING, SODIUM CHLORIDE— 510(k) K922729

Substantially Equivalent for Some Indications

Sparta Surgical Corp.

FDA 510(k) clearance K922729 for SPARTA WET DRESSING, SODIUM CHLORIDE, Substantially Equivalent for Some Indications on 1992-11-23. Applicant: Sparta Surgical Corp..

Clearance details

Applicant: Sparta Surgical Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1992-06-05
Decision date: 1992-11-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hammonton, NJ, 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.