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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K935483
Device Name E-Z PREP(R) TRAY WITH HIBICLENS(R)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact MARCIA C LEATHAM
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact MARCIA C LEATHAM
Regulation Number878.4370
Classification Product Code
LRO  
Date Received11/15/1993
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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