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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 K981329
Device Name FETH-R-KATH
Applicant
EPIMED INTERNATIONAL, INC.
P.O. BOX 1128
GLOVERSVILLE,  NY  12078
Applicant Contact DONALD HENDERSON
Correspondent
EPIMED INTERNATIONAL, INC.
P.O. BOX 1128
GLOVERSVILLE,  NY  12078
Correspondent Contact DONALD HENDERSON
Regulation Number868.5120
Classification Product Code
BSO  
Date Received04/13/1998
Decision Date 08/26/1998
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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