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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K771827
Device Name INTRAVENOUS FILTER W/FLASH BULB
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 Number880.5440
Classification Product Code
FPB  
Date Received09/19/1977
Decision Date 10/13/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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