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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K934011
Device Name MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
Applicant
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Applicant Contact MADELEINE F NUCI
Correspondent
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Correspondent Contact MADELEINE F NUCI
Regulation Number884.4340
Classification Product Code
HDB  
Date Received08/17/1993
Decision Date 05/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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