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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 K843473
Device Name PHARMA-PLAST INSULIN SYRINGE
Applicant
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact DOUGLASS M BENNETT
Correspondent
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact DOUGLASS M BENNETT
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/06/1984
Decision Date 10/31/1984
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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