AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR— 510(k) K895700

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K895700 for AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR, Substantially Equivalent on 1990-04-02. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1989-09-22
Decision date: 1990-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.