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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 K891465
Device Name OBSTETRIC CUP (MODIFICATION)
Applicant
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Applicant Contact GEORGE O'NEIL
Correspondent
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Correspondent Contact GEORGE O'NEIL
Regulation Number884.4340
Classification Product Code
HDB  
Date Received03/15/1989
Decision Date 05/11/1989
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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