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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 K861050
Device Name BIOPSY ADAPTER H4222W
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact HOWARD, II
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact HOWARD, II
Regulation Number878.4800
Classification Product Code
GDF  
Date Received03/19/1986
Decision Date 04/02/1986
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
Predetermined Change
Control Plan Authorized		 No
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