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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K780559
Device Name DISPOSABLE INFUSION SET
Applicant
KS MEDICAL SUPPLY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KS MEDICAL SUPPLY CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/05/1978
Decision Date 06/06/1978
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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