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Company-Registration
1351705537
Device Listing 1351705537
Listing Summary
#
Listing key
1351705537
Premarket submission
K223161
Device
OXY-1 System
Applicant
Abiomed, Inc.
Product code
DTZ
Decision date
2023-02-23
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
1514
1220648
1220648
ABIOMED, INC.
1
N
2026-01-01
22 Cherry Hill Dr DANVERS MA US 01923
283352
3014990448
3014990448
Breethe, Inc.
1
N
2026-01-01
1500 Joh Ave #190 Halethorpe MD US 21227