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Company-Registration
1639973879
Device Listing 1639973879
Listing Summary
#
Listing key
1639973879
Premarket submission
K201440
Device
ROTEM sigma Thromboelastometry System
Applicant
Tem Innovations GmbH
Product code
JPA
Decision date
2022-07-08
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
29960
1217183
1217183
INSTRUMENTATION LABORATORY CO.
1
N
2026-01-01
180 Hartwell Rd. Bedford MA US 01730
337646
3037000637
3037000637
INSTRUMENTATION LABORATORY CO. - Devens
1
Y
2026-01-01
11 Grant Road Devens MA US 01434