FDA device listing

CM-1501 ACL Disposable Procedure Kit

FDA device listing 1924762510 · Life Science Outsourcing, Inc.

Key facts

Proprietary names CM-1501 ACL Disposable Procedure Kit
Owner/operator Life Science Outsourcing, Inc.
Owner/operator number 10024857
Product codes GEA
Device names GEA - Cannula, Surgical, General & Plastic Surgery
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments LIFE SCIENCE OUTSOURCING, INC.
Establishment registrations 2031093
FEI numbers 3001236549
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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