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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, Short-Term Less Than 30 Days
510(k) Number K771573
Device Name DUO-CATH FEMORAL
Applicant
Medical Device Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Device Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/15/1977
Decision Date 09/15/1977
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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