OH-HARRIS— 510(k) K801388

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K801388 for OH-HARRIS, Substantially Equivalent on 1980-07-28. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code KIH
Advisory panel: Orthopedic
Date received: 1980-06-13
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.