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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 K023233
Device Name EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
Applicant
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact JON CAPAROTTA
Correspondent
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact JON CAPAROTTA
Regulation Number868.5120
Classification Product Code
BSO  
Date Received09/27/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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