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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amniotome
510(k) Number K850758
Device Name AMNIGLOVE & AMNICOT
Applicant
Go Medical Industries Pty. , Ltd.
20, Denis St.
Subiaco 6008
Western Australia,  AU
Applicant Contact GEORGE O'NEIL
Correspondent
Go Medical Industries Pty. , Ltd.
20, Denis St.
Subiaco 6008
Western Australia,  AU
Correspondent Contact GEORGE O'NEIL
Regulation Number884.4530
Classification Product Code
HGE  
Date Received02/25/1985
Decision Date 04/15/1985
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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