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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 K771381
Device Name IV CATHETER HUB
Applicant
JELCO LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JELCO LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/26/1977
Decision Date 10/13/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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