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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 K852402
Device Name NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
Applicant
North American Instrument Corp.
NY  12839
Applicant Contact PHILIP H MORSE
Correspondent
North American Instrument Corp.
NY  12839
Correspondent Contact PHILIP H MORSE
Regulation Number878.4800
Classification Product Code
FZX  
Date Received06/06/1985
Decision Date 07/11/1985
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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