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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 K896019
Device Name MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact CHET VANHOF
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact CHET VANHOF
Regulation Number878.4800
Classification Product Code
GAA  
Date Received10/16/1989
Decision Date 01/03/1990
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
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