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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K900082
Device Name MAXX 470 CORE BIOPSY GUN
Applicant
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Applicant Contact CHET VANHOF
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Correspondent Contact CHET VANHOF
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/05/1990
Decision Date 06/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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