FDA device listing

Lifestyles Assorted Flavors

FDA device listing 1927633471 · PARADISE MARKETING SERVICES

Key facts

Proprietary names Lifestyles Assorted Flavors
Owner/operator PARADISE MARKETING SERVICES
Owner/operator number 9039717
Premarket submissions K000408
Product codes HIS
Device names HIS - Condom
Device class Class II
Classification regulations (21 CFR) 884.5300
Review panels Obstetrics/Gynecology
Registered establishments PARADISE MARKETING SERVICES
Establishment registrations 2086832
FEI numbers 3002921123
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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

Browse all FDA device listings