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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 K830406
Device Name NON-STERILE CATHETER REPAIR KITS
Applicant
EVERMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EVERMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/07/1983
Decision Date 03/01/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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