FDA device listing

Lacevo Wearable Breast Pump (Model S70)

FDA device listing 1842151288 · Lacevo Inc

Key facts

Proprietary names Lacevo Wearable Breast Pump (Model S70)
Owner/operator Lacevo Inc
Owner/operator number 10092600
Premarket submissions K250829
Product codes HGX
Device names HGX - Pump, Breast, Powered
Device class Class II
Classification regulations (21 CFR) 884.5160
Review panels Obstetrics/Gynecology
Registered establishments LACEVO INC
Establishment registrations 3035371451
FEI numbers 3035371451
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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