MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT— 510(k) K913324

Substantially Equivalent

Neward Enterprises, Inc.

FDA 510(k) clearance K913324 for MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT, Substantially Equivalent on 1992-06-22. Applicant: Neward Enterprises, Inc..

Clearance details

Applicant: Neward Enterprises, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1991-07-25
Decision date: 1992-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cucamonga, CA, 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.