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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 K980976
Device Name AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
Applicant
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JOESEPH S TOKARZ
Correspondent
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JOESEPH S TOKARZ
Regulation Number884.4340
Classification Product Code
HDB  
Date Received03/16/1998
Decision Date 08/21/1998
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
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