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
1827908289
Device Listing 1827908289
Listing Summary
#
Listing key
1827908289
Premarket submission
K980448
Device
MODEL PS-1 PENA MUSCLE STIMULATOR
Applicant
Radionics, Inc.
Product code
IPF
Decision date
1998-04-03
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
12975
1222895
1000120652
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc
1
N
2020-04-25
85 Rangeway Road Building 2, Floor1 N Billerica MA US 01862
12978
3003418325
3003418325
Integra LifeSciences Corporation
1
Y
2026-01-01
1100 Campus Road Princeton NJ US 08540