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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, surgical, instrument
510(k) Number K860160
Device Name OPERATING ROOM TRAY
Applicant
MEDICAL DESIGN CONCEPTS, INC.
5741 PALMER WAY
CARLSBAD,  CA  92008
Applicant Contact RONALD BERTANZI
Correspondent
MEDICAL DESIGN CONCEPTS, INC.
5741 PALMER WAY
CARLSBAD,  CA  92008
Correspondent Contact RONALD BERTANZI
Regulation Number878.4800
Classification Product Code
FSM  
Date Received01/16/1986
Decision Date 02/27/1986
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
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