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Company-Registration
1185029424
Device Listing 1185029424
Listing Summary
#
Listing key
1185029424
Premarket submission
K161222
Device
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
Applicant
Pentax Medical
Product code
FDT
Decision date
2018-02-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
85642
2518897
1000080301
PENTAX of America, Inc.
1
Y
2026-01-01
3 Paragon Drive MONTVALE NJ US 07645
10490
9610877
3008185830
Paresh Patel
1
N
2026-01-01
3 Paragon Drive Montvale NJ US 07645
10488
3003782610
3003782610
HOYA Corporation PENTAX Lifecare Division
1
N
2026-01-01
30-2 Okada, Aza-Shimomiyano, Tsukidate KURIHARA-SHI Miyagi JP 987-2203