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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 K885149
Device Name NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
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 Received12/15/1988
Decision Date 01/26/1989
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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