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FDA 510(k) Application Details - K092827
Device Classification Name
Forceps, Obstetrical
More FDA Info for this Device
510(K) Number
K092827
Device Name
Forceps, Obstetrical
Applicant
DIMEDA INSTRUMENTE GMBH
SCHWARZWALDSTRABE 5
TUTTLINGEN 78532 DE
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Contact
ANDREA PECSI
Other 510(k) Applications for this Contact
Regulation Number
884.4400
More FDA Info for this Regulation Number
Classification Product Code
HDA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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