Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1865018842
Device Listing 1865018842
Listing Summary
#
Listing key
1865018842
Premarket submission
K841362
Device
TIDAL DISTENSION IRRIGATION SET
Applicant
Abbott Laboratories
Product code
GBX
Decision date
1984-08-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
3008
1047843
1047843
ISOMEDIX OPERATIONS INC.
1
N
2026-01-01
2072 Southport Rd SPARTANBURG SC US 29306
2998
1319660
1000136478
ISOMEDIX OPERATIONS INC.
1
N
2026-01-01
23 ELIZABETH DR. CHESTER NY US 10918
3004
2648623
2648623
STERIS ISOMEDIX PUERTO RICO, INC.
1
N
2026-01-01
KM 1 7, STATE Road, 690 BARRIO SABANA HOYOS Alts De Cerro Gordo 3&4 PR US 00692