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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K913815
Device Name AUTOMATED BIOPSY DEVICE, MODIFICATION
Applicant
Hart Enterprises, Inc.
2131 Martindale SW
Wyoming,  MI  49509
Applicant Contact ALAN TAYLOR
Correspondent
Hart Enterprises, Inc.
2131 Martindale SW
Wyoming,  MI  49509
Correspondent Contact ALAN TAYLOR
Regulation Number878.4800
Classification Product Code
DWO  
Date Received08/26/1991
Decision Date 10/30/1991
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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