FDA 510(k) Application Details - K111681

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K111681
Device Name	Spatula, Cervical, Cytological
Applicant	PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. GUILFORD, ME 04443 US Other 510(k) Applications for this Company
Contact	WILLIAM M YOUNG 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	06/15/2011
Decision Date	01/19/2012
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