510(k) K781668— GAMMA RADIATION STERILIZATION PRECEDURE

Substantially Equivalent

Cutter Laboratories, Inc.

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code KYJ
Advisory panel: Orthopedic
Date received: 1978-09-28
Decision date: 1978-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

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.