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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K810795
Device Name INSTAFIL
Applicant
Instafil, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instafil, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5025
Classification Product Code
KPE  
Date Received03/23/1981
Decision Date 06/12/1981
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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