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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K894879
Device Name 16GA X 10 MIDDLE SIZE 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 Number868.5150
Classification Product Code
BSP  
Date Received08/01/1989
Decision Date 11/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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