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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 K823521
Device Name STERILE HD CVP TRAY
Applicant
Bill Dude Hospital Disposables, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bill Dude Hospital Disposables, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/29/1982
Decision Date 04/08/1983
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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