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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 K981260
Device Name KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
Applicant
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Applicant Contact WM D WALLACE
Correspondent
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Correspondent Contact WM D WALLACE
Regulation Number884.4340
Classification Product Code
HDB  
Date Received04/06/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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