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DTF – Tools, Pacemaker Service
Tools, Pacemaker Service
FDA product code
DTF
· Class I (low risk) · 21 CFR 870.3730 ·
Cardiovascular
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Telectronics, Inc.
1
Cardiac Pacemakers, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K875147
Torque Hex Wrench
DTF · Traditional
Cardiac Pacemakers, Inc.
01/27/1988
SE
K781179
Wrench, Gexagon, Driver
DTF · Traditional
Telectronics, Inc.
07/27/1978
SE