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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 K904172
Device Name ACCUPLACE (TM)
Applicant
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Applicant Contact ROGER BRINK
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Correspondent Contact ROGER BRINK
Regulation Number878.4800
Classification Product Code
GDF  
Date Received09/11/1990
Decision Date 11/21/1990
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
Recalls CDRH Recalls
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