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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 K894873
Device Name 16 GA X 10 BULLET POINT NEEDLE
Applicant
R. J. DOYLE, INC.
P.O. BOX 278
SPIRIT LAKE,  ID  83869 -2179
Applicant Contact N HAMACHER,MD
Correspondent
R. J. DOYLE, INC.
P.O. BOX 278
SPIRIT LAKE,  ID  83869 -2179
Correspondent Contact N HAMACHER,MD
Regulation Number878.4800
Classification Product Code
GAA  
Date Received08/01/1989
Decision Date 09/22/1989
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
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