RHYNOSTAT H-12 & V-22— 510(k) K852349

Substantially Equivalent

Remesta Medical Corp.

FDA 510(k) clearance K852349 for RHYNOSTAT H-12 & V-22, Substantially Equivalent on 1985-09-03. Applicant: Remesta Medical Corp..

Clearance details

Applicant: Remesta Medical Corp.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1985-05-31
Decision date: 1985-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Hyde Park, NY, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.