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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 K840202
Device Name EPIDURAL CATHETER
Applicant
Aries Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aries Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5120
Classification Product Code
BSO  
Date Received01/19/1984
Decision Date 02/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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