CMI VACUUM DELIVERY SYSTEM #003C AND #004C— 510(k) K881306

Substantially Equivalent

Challenge Mfg., Inc.

FDA 510(k) clearance K881306 for CMI VACUUM DELIVERY SYSTEM #003C AND #004C, Substantially Equivalent on 1988-06-13. Applicant: Challenge Mfg., Inc..

Clearance details

Applicant: Challenge Mfg., Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1988-03-28
Decision date: 1988-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bend, OR, US

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Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

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.