FDA 510(k) Application Details - K131630

Device Classification Name	Device, Specimen Collection   More FDA Info for this Device
510(K) Number	K131630
Device Name	Device, Specimen Collection
Applicant	PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 GUILFORD, ME 04443 US Other 510(k) Applications for this Company
Contact	MEHDI KARAMCHI Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2013
Decision Date	10/21/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review