FDA 510(k) Application Details - K891465

Device Classification Name Extractor, Vacuum, Fetal

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510(K) Number K891465
Device Name Extractor, Vacuum, Fetal
Applicant GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH 6008 AS
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Contact GEORGE O'NEIL
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Regulation Number 884.4340

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Classification Product Code HDB
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Date Received 03/15/1989
Decision Date 05/11/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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