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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 K913324
Device Name MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
Applicant
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Applicant Contact JOHN T MURRAY
Correspondent
NEWARD ENTERPRISES, INC.
P.O. BOX 725
9251 ARCHIBALD AVENUE
CUCAMONGA,  CA  91730
Correspondent Contact JOHN T MURRAY
Regulation Number884.4340
Classification Product Code
HDB  
Date Received07/25/1991
Decision Date 06/22/1992
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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