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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 K895700
Device Name AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
Applicant
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number884.4340
Classification Product Code
HDB  
Date Received09/22/1989
Decision Date 04/02/1990
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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