SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)— 510(k) K964403

Substantially Equivalent

The First Years, Inc.

FDA 510(k) clearance K964403 for SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068), Substantially Equivalent on 1997-01-13. Applicant: The First Years, Inc..

Clearance details

Applicant: The First Years, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1996-11-04
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, MA, US

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Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.