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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, conduction, anesthetic
510(k) Number K171193
Device Name Certa Catheter
Ferrosan Medical Devices SP. Z O.O.
Koksowa 3
Szczecin,  PL 70-031
Applicant Contact Elzbieta Porebska-Guillemant
Ferrosan Medical Devices SP. Z.O.O. c/o Promedic LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Correspondent Contact Paul Dryden
Regulation Number868.5120
Classification Product Code
Date Received04/24/2017
Decision Date 12/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No