FDA 510(k) Application Details - K012070

Device Classification Name	Source, Chemiluminescent Light   More FDA Info for this Device
510(K) Number	K012070
Device Name	Source, Chemiluminescent Light
Applicant	TRYLON CORP. 970 WEST 190TH ST., SUITE 850 TORRANCE, CA 90502-1037 US Other 510(k) Applications for this Company
Contact	MARTIN L LONKY Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	MPU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2001
Decision Date	11/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review