FDA 510(k) Application Details - K092827

Device Classification Name Forceps, Obstetrical

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510(K) Number K092827
Device Name Forceps, Obstetrical
Applicant DIMEDA INSTRUMENTE GMBH
SCHWARZWALDSTRABE 5
TUTTLINGEN 78532 DE
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Contact ANDREA PECSI
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Regulation Number 884.4400

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Classification Product Code HDA
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Date Received 09/14/2009
Decision Date 01/08/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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