FDA 510(k) Application Details - K001261

Device Classification Name Table, Obstetric (And Accessories)

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510(K) Number K001261
Device Name Table, Obstetric (And Accessories)
Applicant LUNEAU GYNECOLOGIE SA
BP 252
CHARTRES CEDEX 28005 FR
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Contact BERNARD HOEL
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Regulation Number 884.4900

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Classification Product Code KNC
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Date Received 04/19/2000
Decision Date 06/08/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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