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
2032236119
Device Listing 2032236119
Listing Summary
#
Listing key
2032236119
Premarket submission
K962632
Device
OMNIPULSE/OMNIPULSE-MAX
Applicant
Trimedyne, Inc.
Product code
GEX
Decision date
1997-01-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
69077
1419951
1419951
TRIMEDYNE, INC.
1
N
2026-01-01
519 N. Smith Avenue, Suite 105 Corona CA US 92878