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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 K960549
Device Name MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
Applicant
Neward Enterprises, Inc.
P.O. Box 725
Cucamonga,  CA  91730
Applicant Contact ALLYSON CARMACK
Correspondent
Neward Enterprises, Inc.
P.O. Box 725
Cucamonga,  CA  91730
Correspondent Contact ALLYSON CARMACK
Regulation Number884.4340
Classification Product Code
HDB  
Date Received02/08/1996
Decision Date 08/29/1996
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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