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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K875148
Device Name MEDICRAT, HYPODERMIC SYRINGES & NEEDLES
Applicant
Knowltech Ind., Inc.
10275 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact KATHLEEN G KIM
Correspondent
Knowltech Ind., Inc.
10275 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact KATHLEEN G KIM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/15/1987
Decision Date 02/11/1988
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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