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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Needle, Surgical
510(k) Number K845038
Device Name BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
Applicant
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Applicant Contact MICHAEL P CODY
Correspondent
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Correspondent Contact MICHAEL P CODY
Regulation Number878.4800
Classification Product Code
GDF  
Date Received12/27/1984
Decision Date 03/11/1985
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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