FDA 510(k) Application Details - K083012

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K083012
Device Name	Spatula, Cervical, Cytological
Applicant	OTTO BOCK PUR LIFE SCIENCE GMBH MAX-NAEDER-STR 15 DUDERSTADT, LOWER SAXONY 37115 DE Other 510(k) Applications for this Company
Contact	CHRISTIAN SCHULTE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2008
Decision Date	04/09/2009
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	Y
Expedited Review