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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, circular (spiral), scalp and applicator
510(k) Number K910815
Device Name CR SPIRAL ELECTRODE
Applicant
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Applicant Contact ALLYSON C CARMACK
Correspondent
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Correspondent Contact ALLYSON C CARMACK
Regulation Number884.2675
Classification Product Code
HGP  
Date Received02/26/1991
Decision Date 12/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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