Device Listing 1491173437

Listing Summary#

Listing key: 1491173437
Premarket submission: K251447
Device: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Applicant: Terumo Europe N.V.
Product code: FMI
Decision date: 2025-07-08

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
122474	9681413	3001570557	Dina Justice	1	N	2026-01-01	950 Elkton Blvd Elkton MD US 21921