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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K914608
Device Name BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact ROGER W BRINK
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact ROGER W BRINK
Regulation Number878.4800
Classification Product Code
GAA  
Date Received10/17/1991
Decision Date 01/09/1992
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
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