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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 K885090
Device Name HOMER MAMMALOK LOCALIZATION SHIELD
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact ROBERT E FRANKLIN
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact ROBERT E FRANKLIN
Regulation Number878.4370
Classification Product Code
LRO  
Date Received12/12/1988
Decision Date 02/14/1989
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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