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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
GOMEDICAL INDUSTRIES PTY LTD.
20, DENIS ST.
SUBIACO 6008
WESTERN AUSTRALIA,  AU
Applicant Contact GEORGE O'NEIL
Correspondent
GOMEDICAL 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
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