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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 K760005
Device Name SYRINGE, DISPOSABLE, GLASS & PLASTIC
Applicant
Stewart-Naumann Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stewart-Naumann Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/07/1976
Decision Date 08/23/1976
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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