FDA device listing

Resorbable Collagen Wound Dressing

FDA device listing 1821670370 · Young Innovations Inc

Key facts

Proprietary names Resorbable Collagen Wound Dressing
Owner/operator Young Innovations Inc
Owner/operator number 9046427
Premarket submissions K152600
Product codes KGN
Device names KGN - Wound Dressing With Animal-Derived Material(S)
Device class Unclassified
Classification regulations (21 CFR) ORCA1.KGN
Review panels General & Plastic Surgery
Registered establishments SALVIN DENTAL SPECIALTIES, LLC
Establishment registrations 1066741
FEI numbers 3003005156
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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