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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Surgical, Instrument
510(k) Number K854262
Device Name MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
Applicant
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact SCOTT MINDREBO
Correspondent
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact SCOTT MINDREBO
Regulation Number878.4800
Classification Product Code
FZX  
Date Received10/23/1985
Decision Date 12/24/1985
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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