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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 K871503
Device Name BIOPSY NEEDLE GUIDE KIT, STERILE
Applicant
Amedic USA
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Applicant Contact JACK A MOORE
Correspondent
Amedic USA
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Correspondent Contact JACK A MOORE
Regulation Number878.4800
Classification Product Code
FZX  
Date Received04/17/1987
Decision Date 07/10/1987
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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