OSTO-PURE— 510(k) K871738

Substantially Equivalent

Clearchem Corp.

FDA 510(k) clearance K871738 for OSTO-PURE, Substantially Equivalent on 1987-08-12. Applicant: Clearchem Corp..

Clearance details

Applicant: Clearchem Corp.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1987-05-05
Decision date: 1987-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lima, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.