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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 K943938
Device Name MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
Applicant
NEWARD ENTERPRISES, INC.
9251 ARCHIBALD AVE.
P.O. BOX 725
RANCHO CUCAMONGA,  CA  91729 -0725
Applicant Contact ALLYSON C CARMARK
Correspondent
NEWARD ENTERPRISES, INC.
9251 ARCHIBALD AVE.
P.O. BOX 725
RANCHO CUCAMONGA,  CA  91729 -0725
Correspondent Contact ALLYSON C CARMARK
Regulation Number884.4340
Classification Product Code
HDB  
Date Received08/12/1994
Decision Date 05/03/1995
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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