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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 K883744
Device Name MANAN HUBER STYLE INFUSION NEEDLE
Applicant
Manan Medical Products, Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
Manan Medical Products, Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/01/1988
Decision Date 09/28/1988
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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