FDA 510(k) Application Details - K984361

Device Classification Name	More FDA Info for this Device
510(K) Number	K984361
Device Name	ORAL-EZE ORAL FLUID COLLECTION SYSTEM
Applicant	OSBORN LABORATORIES, INC. 14901 WEST 117 ST. OLATHE, KS 66062 US Other 510(k) Applications for this Company
Contact	GILBERT P BOURK III Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/1998
Decision Date	01/13/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review