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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 K911067
Device Name NORCATH VASCULAR ACCESS CATHETERS
Applicant
Norfolk Medical
7307 N. Ridgeway
Skokie,  IL  60076
Applicant Contact MICHAEL J DALTON
Correspondent
Norfolk Medical
7307 N. Ridgeway
Skokie,  IL  60076
Correspondent Contact MICHAEL J DALTON
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/11/1991
Decision Date 06/03/1991
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
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