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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K830233
Device Name NON-STERILE,SINGLE/SOUBLE LUMEN-CATH
Applicant
Evermed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Evermed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/25/1983
Decision Date 02/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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