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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 K023140
Device Name VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
Applicant
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Applicant Contact CHRISTOPHER B LAKE
Correspondent
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Correspondent Contact CHRISTOPHER B LAKE
Regulation Number868.5120
Classification Product Code
BSO  
Date Received09/20/2002
Decision Date 08/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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