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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K770119
Device Name I.V. LOK TM
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 Number880.5210
Classification Product Code
KMK  
Date Received01/21/1977
Decision Date 03/14/1977
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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