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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K950686
Device Name I.V. START KIT
Applicant
James J. Schramm
P.O. Box 406
Lake Villa,  IL  60046
Applicant Contact JAMES J SCHRAMM
Correspondent
James J. Schramm
P.O. Box 406
Lake Villa,  IL  60046
Correspondent Contact JAMES J SCHRAMM
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/14/1995
Decision Date 10/24/1996
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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