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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K790104
Device Name PISTORMATIC
Applicant
Zelby, Burstein, Hartman & Burstein
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zelby, Burstein, Hartman & Burstein
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6920
Classification Product Code
KZH  
Date Received01/16/1979
Decision Date 05/14/1979
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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