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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
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